Lead Optical EngineerResponsible for providing leadership in the direction, planning, strategy and execution of thedevelopment of endoscopes for use with surgical system. This individual will work closely withexternal partners to develop the technical approach, detailed design and implementation path tobring a new laparoscope to market. This position will also oversee the testing and regulatorycompliance for the project, ensuring that the development efforts meet the design controlstandards of a regulated marketplace.Duties:Work with external development partners to determine technical approach and detailedimplementation plan.Engage in design and test activities to supplement external efforts and ensure that marketrequirements are being achieved.Create and develop product documentation, including systems, hardware and softwarespecifications, design descriptions, verification and validation protocols, test reports, engineeringstudies and others as required.Interface with engineering leaders engaged with other aspects of system to ensure that overallclinical and project requirements are met.Coordinate project management activities within optical development.Support FDA product approval submissions (510k, PMA) and CE Marking.Communicate development status and strategy to the Executive Management Team.Qualifications:Bachelor’s degree in Optical Engineering or any other relevant degreeA minimum of 10 years of engineering experience developing optical systems within a medicaldevice industry.A solid working knowledge of regulatory requirements for optical system development,including knowledge of standards such as IEC 60601, ISO 13485, ISO 14971.Experience with electromechanical systems integration strongly preferred.
Excellent project management skills and experience with product development from productconception through launch.Sr. Optical EngineerThe Optical Engineer will develop and prototype optical systems for the CommercialCommunications product line. In this responsibility they also will aid in the integration of theoptical design into the system and the qualification. Responsibilities will include design anddevelopment of optical systems and subsystems. The potential candidate is an individual who isdedicated, articulate, energetic, and results oriented team player with positive attitude andexcellent people skills.KEY RESPONSIBILITIES:Develop and prototype optical system for commercial communications utilizing various opticalelements and sensorsDevelop and implement optical test systems for commercial communicationsWrite detailed optical specifications and coordinate with optics vendorsDesign test methodologies for system level validation and component testData collection and analysis of test links and from field trialsUnderstand and access technical trade-offs and recommend architecture/design direction toreduce cost and manufacturing complexityAid as part of the NPI team in releasing the product to productionMay require technical team leadership of design engineering staff, in a matrix environmentQUALIFICATION - KNOWLEDGE/SKILLS - EXPERIENCE:5+ years of experience as optical engineer working with optical or laser based technology andgood understanding of an optical communication linkExcellent analytical skills and familiar with data processing and analytical software(Matlab/Mathematical or similar)Working programming knowledge in VB/VBA and MatlabHands on experience in aligning complex optical systems
Strong communication skills and prior experience with delivering a product from conceptthrough product development to manufacturingExperience with products that need a thorough understanding of multiple disciplines includingelectrical, mechanical, optical, and software engineeringPrior experience with delivering a product from concept through product development tomanufacturingThe ideal candidate will possess excellent written, verbal, and interpersonal communicationskills, is customer-centric, collaborative, and decisiveOpto-Mechanical EngineerExciting opportunity for an Opto-Mechanical Engineer. The OME will be responsible fordesigning, developing, and implementing a variety of simple to complex systems supportingadvancement of research. This activity requires a thorough knowledge of optical and mechanicalengineering concepts and application. The OME will work collaboratively with researchcustomers and department colleagues. The OME will work on projects from inception at theconcept development stage to completion at the product delivery stage, playing a primary role todevelop designs and products to meet customer specifications.Principal Responsibilities:Designs, develops, assembles, integrates, tests, and optimizes simple to complex opto-mechanical systems for neurobiological research. Applications will include development ofsystems, sub-assemblies and component parts.Studies the project concepts, objectives, priorities, and requirements; analyzes user and potentialuser input.Identifies and establishes performance requirements involving optical stress, strain, thermal,shock, vibration, acoustic, and radiation inputs and other system parameters and variables asneeded.Collaborates in the development of robust systems that can be distributed and replicated atmultiple sites. Solid documentation management skills are required.Assists with interpretation of requirements from research groups on short and long-termprojects.Translates the requirements into mechanical concepts, designs and plans.Executes designs in a 3D MCAD and optical design environment and performs design analysis,as needed.
Creates detailed drawings and perform document (revision) control.Estimates up front costs, and then tracks time, effort, and supplies and materials costs to enableproper charges to customers.Preferred Qualifications:BS/MS or above. Physics, Mechanical Engineering or equivalent work- related experiencerequired. MS in Physics, Optics, and Optical Engineering strongly preferred.Experience working in a laboratory environment helpful.Minimum of 5 years experience in developing Optical/Opto-Mechanical Systems.Experience working in instruments for neurobiological research, preferred.Ability to write software using LabView, Matlab, or Visual Studio tools is preferred.Requires technical aptitude - complete knowledge of optical and mechanical engineering theory,principles and practice. Experience with design and implementation of instrumentation and/orautomation required.Ability to contribute to and understand core project requirements, which will be of a scientific aswell as technical nature, and suggest multiple options.Ability to perform design work in a 3D CAD modeling environment. Autodesk Inventor®experience preferred.Ability to perform optical designs in appropriate software. ZEMAX or OSLO experiencepreferred.Experience with optical simulation tools required. Tracepro preferred.Excellent detail drafting skills required. Knowledge of geometric dimensioning and tolerancingpreferredAbility to generate a detailed, costed Bill of Materials including commercially sourcedcomponentsMetrology Systems EngineerNew Product DevelopmentThe candidate will be responsible for aiding in the development of new and supporting currentmetrology systems by focusing on system integration, programming, and data analysis.
Lead hardware/software integration of fully custom and commercial-off-the-shelf metrologysystemsInvestigate improvements to current systems along with new technologies to increase corecompetenciesDevelop proof-of-concept systems (hardware and software)Work with vendors on requirements building, development strategy, and acceptance testing forproduction applications and metrology systemsProvide troubleshooting and advanced analysis of metrology data (large data sets, imageprocessing, root cause investigations) for project specific issuesContribute to acceptance testing of systems (validation, IQ, OQ, PQ)Key Performance IndicatorsContinued innovation in metrology systems related to new product development projects.Support advanced metrology instrumentation in use by development teams.Education :Prefer electrical engineer or optical/mechanical/computer science/computer engineer with focuson systems and instrumentation. BS+5 yrs experience, MS+2 yrs experience.Experience:Hardware control (precision motion, cameras, sensors)Integration of multiple components into working systemC#, LabView, MATLABKnowledge of software development life cycle a plusComputer vision, interferometery, profilometery experience a plusExcellent communication in written and verbal formSenior Medical Device Development EngineerThis R&D position will work with the cross-functional core teams through product developmentprocess with the main goal of developing and delivering Volcanos new or existing medicaldevice products to market.
Responsibilities:Design Controls & MethodologyHas mastery over design controls (able to mentor others).Strong knowledge of and ability to perform Product Development Process activities.Competent in design approaches and level of rigor - good track record of successful designs.Basic knowledge and experience with Regulatory requirements associated with design controls.Design CompetenciesConceptualizes, designs, develops and documents - medium to large scale designs - moderatecomplexity.Develops basic catheter /disposable designs, including transducer and optical development andfabrication.Supports optimization of existing designs.Ability to create process maps, value stream maps, CAD drawings, and schematics.Develops and/or guide others in statistical analysis and problem solving. Development ofstatistical rationale plans for development studies techniques including, but not limited toverification and validation plans, DOEs, Gage R&Rs.Define, perform and analyze complex linear experiments and complex DOEs.Performs root cause analysis and implements corrective actions.Performs development and validation of new test methods.Direct others in design, building and testing.Transfers new designs from R&D to production.Design Documentation SkillsMay be a lead on smaller design projects/components, often mentored by a Principal LevelEngineer. Participates in research and/or development activities and acquires good laboratorypractices (GLP).Develops strategies and writes advanced technical reports and test plans.Ability to generate basic test methods and procedures for evaluating designs, processes andproducts.
Ability to draft documentation for components, designs, processes and tools of moderatecomplexity.Basic knowledge and experience in generation of work instructions, preventative maintenanceschedules, documentation for components, tooling, and processes of moderate complexity; ableto perform operator training.Assists in organizing technical design reviews and presents relevant sub-sections.Establishes topologies and architects documentation plans for medium complexity developmentefforts.Discipline Leadership ResponsibilitiesParticipates in development efforts as a Medical Device Development Core team representative.Mentors technicians and junior members of the team.Scientific Research ResponsibilitiesDevelops and conducts/manages laboratory research. Develops domain knowledge based on, andmay contribute to, technical and academic literature.Executes disposable device performance testing.Develops domain knowledge based on technicaland academic literature.Researches new materials and adapts those materials and equipment into design and productionprocesses.Technical CommunicationTeam member or leader within functional area.Communicates with technical resources, across functional areas, outside vendors and internalcustomers to resolve conflicts.Education & Experience:Bachelors of Science and a minimum of 5 years of relevant work experience; or a Master Degreewith a minimum of 3 years of relevant work experience; or a PhD without experience; orequivalent work experience.(Mechanical Engineering, Material Science, Plastics Engineering, or Biomedical Engineeringpreferred).Demonstrate organizational and interpersonal skills working in a cross-functional, regulatedenvironment.
Understanding of theories and principles of domain (preferably in a medical setting).Skills and Abilities:Must have familiarity with cardiology catheterization procedures, tools, and terminology.Ability to work in a team environment to ensure conducive working relationships.Excellent analytical skills.Ability to organize and prioritize workflow in order to meet established time frames andschedules.Assimilate techniques from scientific literature.Develop intellectual property and support patenting process.Remain current in discipline and domain.Support patenting process.Ability to travel up to 25% (domestic and international locations).Proficiency in Microsoft Work, Excel, Powerpoint.Desirable: Solidworks, Statistical Software, Project.Senior Product EngineerRapidly growing medical device company, revolutionizing the industry with a broad suite oftechnologies that make imaging and therapy simpler, more informative and less invasive. Ourproducts empower physicians around the world with a new generation of analytical tools thatdeliver more meaningful information-using ultrasound and light as the guiding elements.Company combining patented MEMs (Micro-Electrical-Mechanical-Systems) devices andproprietary Micro-Optic technology with a highly scalable, automated assembly process toenable the highest performance optical engines for Telecommunications, Industrial, and MedicalImaging applications. We are looking for a successful Senior Product Engineer to join ourmanufacturing team.Job Summary:Provide cross-functional leadership as the "owner" of one or more product lines inManufacturing
Transition new products from development to manufacturingDevelop systems and specifications to ensure manufacturabilityTrain operators so as to minimize Engineering involvement in manufacturingMonitor product quality and performanceCorrelate system performance to subassembly specifications and implement controlsUnderstand product performance at the filter, module, and system levelsPerform root cause analyses on failuresDrive product changes to increase functionality, reduce long term failures, and increaseprofitability by improving manufacturing yields and throughputDevelop robust processes that can leverage engineering and operations expertiseResponsibilities:Develop specifications, processes, performance and test requirements for newly-introducedproducts and new customer configurationsReview Production Test Processes and Data before shipment to ensure compliance withcustomer specification and develop tools and processes for transition to Operations ownershipWork with Quality and Test to debug Production units, address component quality, and ensurequality of shipments to customersDrive customer care/responsiveness by coordinating diagnosis of Product RMAs, performance ofFMAs, and implementation of Corrective ActionsWork with Sales and Marketing to develop specifications for new product variantsQualifications:BS in Engineering or Science, MS desirableKnowledge and Experience:Statistical methods for use of SPC, calculating CpKsWork with MEMS, Lasers, and Micro Optical Assemblies7-10 years prior experience in manufacturing environmentSkills and Abilities:
Action-oriented and adaptable; strong sense of initiative and urgencyTeam leader with excellent communication, influencing, delegating, and coaching skillsPragmatic; calibrates the solution to the problem at handSr. Mechanical EngineerPerforms a variety of engineering assignments utilizing a wide range of engineering principles.Works at engineering lead level involving planning development and design of equipment,processes or facilities.Participates with teams of engineers and/or technicians as necessary to achieve projectcompletion.Ensures that manufacturing equipment meets company specifications, schedules and budgets.Facilitates and conducts engineering assignments involving projects of moderate magnitude andscope.Coordinates projects with sub-contractors from beginning of design process through installationand start-up processes.Acts as advocate for continuous improvement of technology and processes.Adheres to environmental policy and procedures and supports department environmentalobjectives.Plans, conducts and directs equipment engineering assignments for production support in areasof uptime, cycle time and yield.Manages multiple projects across various disciplines.Performs concept analysis and justification of capital projects and manage capital projectexecutions.Supervises teams of inside and outside designers, consultants and contractors.Prepares equipment, process, safety and materials specifications and conducts technical analysisof vendor proposals.Qualifies new equipment and performs vendor and site acceptance testing to meet projectobjectives.
Provides training to Operations engineers and technicians to operate, troubleshoot and maintainnew equipment.Qualifications:Bachelors Degree in Mechanical Engineering BSME with a minimum of 4 years engineeringexperience in working in a manufacturing environment is required for this role.Experience in equipment development and installation and qualification of machinery andconstruction is an asset. Project management, is required.A minimum of 1 years experience working in regulated environment (i.e. Medical Device,Aerospace, Automotive, Silicone chips, etc) is required.The ability to plan, conduct and direct equipment engineering assignments for productionsupport is required for this position.This position will require the ability to participate in Cross Functional Teams both internal andexternal.Knowledge and understanding and application of principles, concepts and practices ofmanufacturing engineering is required. 2D & 3D CAD software experience is an asset.Excellent written and oral communication skills required. Excellent organizational skillsrequired.Senior Process EngineerSr. Process Engineer to perform a variety of engineering assignments utilizing a wide range ofengineering principles.Works at an advanced technical expertise level involving planning development and design ofmaterials, equipment, and/or processes.Reviews progress and evaluates results of multiple projects across various disciplines.Coordinates teams of engineers and/or technicians as necessary to achieve project completion.Facilitates and conducts engineering assignments involving projects of major magnitude andscope.Takes a leading position in activities involved with outside vendors from beginning of designprocess through feasibility and start-up processes.Acts as advocate for continuous improvement of technology and processes.
Adheres to environmental policy and procedures and supports department environmentalobjectives.Plans, conducts and directs research, development or engineering assignments.Manages multiple projects across various disciplines.Project management internally as well asoutside vendors (overseas travel necessary).Performs concept analysis and justification of capital and expense projects for future projectdevelopment of a medium complexity.Prepares equipment, process, safety and materials specifications and conducts technical analysisof vendor proposals.Develops and implements material, equipment and/or process enhancements that will improveproduct quality and yield, process sustainability and efficiency, and safety.Performs other related duties as assigned by management.Basic Qualifications:Bachelors Degree - Engineering/Material/Natural/Physical Science or equivalent requiredexperience. 5+ years engineering experience in project management and science related fieldrequired.Thorough knowledge and complete understanding and application of principles, concepts andpractices of Materials Science; preferably including polymers.Experience in Operations or Manufacturing is preferred.Knowledge of process validation is preferred in this role.Excellent written and oral communication skills required.Excellent organizational skills required. This position will required travel up to 25%.Sr. Quality EngineerWork supporting advanced cardiac imaging catheters and systems development programs.Responsible for driving design and process quality into new catheter and system products andprocesses.Responsibilities:
Participate on the technical teams that successfully develop and launch new advanced cardiacimaging catheters and systemsOwn and lead quality assessment and improvement for new advanced cardiac imaging cathetersand systemsDetermine and Establish use, component and process failure modes, effects, likelihood ofoccurrence and risk mitigation strategies together with the technical teamDevelop and Implement streamlined inspection data collection processes including trendreporting and establishment of quality goalsInteract with Engineering, Marketing, Regulatory, Manufacturing, Purchasing, Clinical, andother departments as appropriateEducation:B.S. degree in engineering, preferably mechanical or electricalKnowledge and Experience:8+ years quality engineering experience in the field of medical devices including productdevelopment and design controlsExperience with electro-mechanical assemblies, systems and softwareStrong analytical skills with a working knowledge of statistical quality methods, samplingmethodologies, and Design of ExperimentsKnowledgeable of FDA regulations, Quality System Regulations (QSR), and ISO 13485requirementsExperience in Risk Management, FMEAs, and applying ISO 14971Track record of success and appropriate cultural fitSkills and Abilities:Strong computer skills, generating reports, spreadsheets, presentations.Strong presentation skills, both written and oralPractical application of Design of Experiments (DOE)Ability to work effectively with remote teams and operationsDesirable Qualifications:
Experience with medical device development and manufacturingExperience with IEC 62304Experience with IEC 60601-1 3rd editionFluidics Systems EngineerResponsible for the technical leadership in establishing world class advanced fluid handlingsystems for the company’s product offering. The position will be involved in leadership bycontributing in the continuous improvement of the currently offered dispensing and fluidhandling systems and joint development integrations of best in class solutions.ESSENTIAL DUTIES & RESPONSIBILITIES include the following.Research and Development: Investigate and assess industry approaches of best in class fluidhandling / dispensing solutions within the sub-microliter range to help guide and assist in thedevelopment of products. Interaction with industry leaders will be required in this capacity. Leadthe development of instrumentation fluid handling subsystems.Subject Matter Expert: Lead the advancement of core fluid handling discipline. Identifyopportunities for cost reductions and quality improvements in our fluid handling technologies.Perform engineering analysis and modeling on critical form and function areas. Interact in aprofessional manner frequently with internal associates, external customers, suppliers andindustry leaders. Travel to support customers, Sales, Business Development and Research needsrelated to fluid mechanics and handling. Mentors and coaches colleague engineers, technicians,field service technicians, and manufacturing personnel.Technology Application: Develop fluid dispensing and fluid handling devices usingnew/existing technology within the industry. Apply or recommend the correct fluid handlingtechnology to meet each project’s unique needs. Document and communicate technical solutionsfor intellectual property requirements.Project Team Participation: Serve as a project team member, accountable to the projectdeliverables and schedule. Cooperate with other disciplines in development activities includingsoftware design, controls design, electrical design, mechanical design, document control, qualityengineering, test engineering, manufacturing and field support services. Promotes / utilizescorporate processes including: design and development, verification and validation, engineeringchange control, and risk assessment for all designs
Engineer/Scientist Microfluidics and Sensor TechnologiesWorldwide developer, manufacturer, and distributor of critical care and hemostasis in vitrodiagnostic instruments and related reagents for use primarily in hospital laboratories and hospitalpoint-of-care locations. Our products integrate a wide variety of technologies and disciplines,such as biochemistry, chemical engineering, electrochemistry, electro-optics, software,electronics, mechanical engineering, and microfluidics.Ideally the candidate should have first project experiences in the development of integratedmicrosystems for life science applications with a focus on biochemical assay technologies.Position SummaryThis position will provide a key role in developing the pipeline of new products throughengineering innovation primarily in the technology area of microfluidic systems for diagnosticlaboratory instrumentation and will encompass all aspects of system development.You will be working in the Dept of Technology Development as a member of multidisciplinaryR&D project teams on highly innovative medical instruments.The position will give the opportunity to work on design, prototyping, and optimization ofinstrument systems that integrate fluidics, electronics, robotic mechanisms, optics, thermalcontrol, and chemistry analysis.You will be able to use your engineering education to satisfy product design challenges such as:Research and develop system and microfluidic architectures for fully automated medicaldiagnostic instruments, working in a multidisciplinary team.Design, develop, simulate and evaluate liquid handling systems and sensors.Design and perform critical experiments and engineering studies relating to system requirementsand architectureThe ideal candidate will have a recent degree in micro engineering with a strong background inmicrofluidics, nanotechnology and a strong understanding of the fundamentals of fluidic theory.You will have a track record of product innovation, used to prototype design and build, ideallywith some experience of taking concepts through to full product development.The position includes technical concept development, systems modeling and the design andcharacterization of fluidic subsystems for new and existing blood analysis products.Principal Duties & Responsibilities:Medical instrument system design and development within a multidisciplinary team
Design and development of liquid handling systems including fluidics and sensor technologiesfrom concept through to manufacture and system integration.Keep up to date with external developments in the area of microfluidic systems for in vitrodiagnosticsKnowledge Requirements:Comprehensive knowledge of Microfluidic Engineering, coupled with a working knowledge ofthe other engineering disciplines e.g. mechatronics, sensor technologies and material sciencesExtensive knowledge in materials and component selection.‘Good team player; able to work in a close-knit teams with design, analysis, integration and testengineers is mandatory.Minimum QualificationsMS/PhD in microsystems technology, mechanics, (bio) physics or equal qualification,specialized in microfluidics and nanotechnology with a broad knowledge in mechatronics andmaterial sciences.Ideally with first project experiences in the development of integrated microsystems for lifescience applications with a focus on biochemical assay technologies.Opto-Mechanical/Mechanical EngineerThe major responsibilities of the Instrumentation Engineer include:Working with R&D personnel to convert a scientific/technical concept to an engineeringconcept. This include to provide conceptual designs to the specified mechanical problems basedon the known solutions, to develop innovative solutions with R&D scientists, and to assess theperformance of the proposed solutions and finalize the concept for the engineering design andprototyping,Working with engineering department to transfer the engineering concept and solution to theproduct design, review, prototype and finalization,Testing and evaluating the designed system against the performance specification, and furtherimproving the design with engineering department until the design meets the specification andfinalized, helping to develop manufacturing processes and procedures for production.
The qualified candidate must have a Bachelor degree in Mechanical Engineering or OpticalEngineering.Two-years experience in opto-mechanical system related design and analysis,Understanding of opto-mechanical design principles and solid background in opto-mechanicalsystems,Capability in quantitative analysis of mechanical systems using software tools (such as FEA),including stress, deformation, material characteristics and their impacts to the designs,Being able to use CAD software, preferably UniGraphics, to create 3D models for theconceptualization.Sr. Researcher - Flexible ElectronicsA multidisciplinary R&D laboratory pursuing applied research on new and differentiatedmaterials, devices, advanced algorithms, and systems, with applications to displays, solar energycreation, energy management, biosensors, mobile health, and solid state lighting.Collaboratesextensively with product groups and its R&D labs worldwide as well as with universities, USgovernment, and other companies.Seeking a talented senior researcher to lead a dynamic R&D effort in the area of flexible displaysand printed electronics. This employee will drive the development of a strong in-house programin fields including displays, sensors, and lighting. This leadership role will be conducted incollaboration with management and other senior personnel. The employee will set the vision andlead a team of researchers, in addition to his/her own role as technical contributor. S/He will beresponsible for technically managing existing projects and will be a key person for generatingidea seeds that can provide future technology directions. S/He must have the technical andleadership skills to carry ideas from concept level to feasibility stage, within tight timeframes,and by bringing together other internal and external resources as appropriate. The employee willbe expected to multitask, contributing to several projects within the organization. S/He willorganize, conduct and interpret experiments and simulations, analyze data, and presentactionable information to customers and partners in Japan. The employee will be responsible forproject management at the program level and will be expected to act as mentor for junior-levelemployees. The employee will present pertinent information (progress, results, new proposals) todomestic and international audiences.Must – Skills / Knowledge Requirements:Ph.D. degree in Science or Engineering with emphasis on vacuum-free microelectronic materialsand devices.
At least 10 years of experience, focused on flexible electronics, process integration and relatedsystem design and development.Excellent leadership skills as evidenced by past record in building and guiding teams towardssuccessful project completions.Excellent theoretical understanding of solution processed material systems (i.e. organic andinorganic semiconductors), device physics, device integration and device characterization andtroubleshooting.Experience with printing technologies, as they pertain to electronic device fabrication.Excellent understanding of flexible electronics markets and opportunities.Past experience with idea-to-technology transfer cycles. Ability to generate and quickly screennew ideas and technologies.Very strong project management and mentoring skills.Very strong communication skills.Very strong presentation skills and ability to present at variouslevels (i.e. technical update, management update, executive update).Knowledge of the various applications of flexible electronics.