Medical Devices - Multiple Roles

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Medical Devices - Multiple Roles

  1. 1. Medical Device Engineering - Multiple LocationsDirector of Product DesignLocation: TexasSummary: This position is responsible for providing a continuous stream of best in class designsthat address unmet medical needs with innovative value-added solutions.Minimum Education Requirements: Advanced degree in Mechanical, Materials, Biomedicalor equivalent Scientific/Engineering discipline is strongly preferred.Minimum Experience Requirements: Demonstrated progressive leadership of a new productdesign team comprising directors, principal engineers and 15 or more engineers that delivers of acontinuous pipeline of best in class medical device products.Demonstrated capability to establish and maintain an environment of innovation that helps assureongoing understanding of unmet medical needs, future trends, and opportunities.Demonstrated proficiency in establishing product design process capabilities including numericalmodelling, rapid prototyping, customer evaluations, product selection, and consideration of highvolume GMP manufacturing technologies.Demonstrated understanding of the design process, design for 6 sigma principles, and a record ofcontinuous improvement.Direct or transferable proficiency engineering and physics principles – especially as related to apolymer materials, optics, and mechanical design.Experience with electro-optical device design is also desirable.Demonstrated participation in regulatory approval, manufacturing transfer and product launchactivities.See other openings:http://www.linkedin.com/in/keithleveneKeith Levenekeith@photonicsgrp.com
  2. 2. Director of Materials Research – Medical deviceLead, coordinate and support Material Research programs for innovating superior materials andproducts for meeting unmet medical needs in accordance with the pipeline strategy and providetechnical support to programs/projects as they advance through the stage-gate process.Responsible for leading and coordinating Material research programs leading to innovative andsuperior products for meeting unmet medical needs.Recruitment, training, growth and development of staff for building a technically strong,motivated and creative research team while cultivating a harmonious and high performing teamculture.Performance standards, performance appraisal, salary raises, promotion, team spirit, morale,creativity and other issues of all of the reporting staff. The director ensures growth of all staff,especially high potentials, in order to prepare future leaders.Generation of necessary program plans in the area of responsibility and, continuously monitoringand ensuring that these programs achieve their key targets as planned.Assures that generated product and material concepts are filed as memorandum of inventions andsupports patent applications.Identification of new product opportunities in accordance with the pipeline strategy throughcontinuous monitoring of the ophthalmic surgery field, consulting with leading surgeons andevaluating ideas/concepts from all internal and external sources.Establish external contract research, recruitment of consultants and subsequent liaisons, scientificpresentations and publications and other activities towards objectives of the department.Coordinate generation of technical documentation resulting from innovative research,establishing proof of science, new material formulations, and assessing preliminary safety andstability of materials.Responsible for actively monitoring surgical practice, competitor activities and patent andscientific literature for significant technical developments relevant to the direction of SurgicalProducts R&D.
  3. 3. Minimum Education Requirements: Advanced degree in Materials, Biomedical or equivalentscientific discipline.Minimum Experience Requirements: 10+ years experience of increasing responsibility.Sr. Engineer IILocation: TexasApply medical device design principles resulting in a product that meets intended customer-based performance requirements, complies with international guidelines, and is transferable tomanufacturing with high yield and throughput potential.Responsibilities:Creating workable concepts and designs as solutions to current medical needsLeading and performing evaluation of concepts/designs with doctors and other stakeholdersusing design of experiments and finite-element analysisGenerating 3D computer models and facilitating fabrication of prototypesDeveloping fabrication and testing procedures for new and more complex conceptsWriting summary reportsEducation:University degree in Mechanical Engineering MS + 5y - PhD preferredExperience:Demonstrated excellence with Mechanical Design, Computer-Aided Design (CAD), Computer-Aided Manufacturing (CAM), and Mechanical Analysis (FEA)
  4. 4. Experience working with and designing small, complex medical devices; especially with moldedplastic componentsExperience working with micromachining equipment such as mills and ultra-precision lathesExperience with manufacturing and testing of optic components a plusInventor/co-inventor of patented commercialized productsPrincipal Optical Engineer – Medical DevicesLocation – MassachusettsLead the technical concept development, systems modeling and optical design. This role willencompass all phases of the evolution of optical instrumentation development for blood analysisproducts.Principal Duties & Responsibilities:Medical optical instrument system design and development within a multidisciplinary teamDesign and development of optical systems from concept through to manufacture and systemintegration.Optical system requirements trade analysisOptical system architecture definitionOptical designGenerate design concepts and documentationPerformance evaluation and testingParticipate in the following activities:Subsystem and component specification definitionSubsystem and component manufacture oversightOptical system alignment and testingBe the technical point of contact for relevant optical system(s).
  5. 5. Mentor more junior colleagues in the area of optical systems design, devise and provide trainingmaterial when necessary.Define and manage the programmatic and technical aspects of work packages relevant to area ofexpertise.Travel 20 - 25%Knowledge Requirements:Comprehensive knowledge of Optical Engineering, coupled with a working knowledge of theother engineering disciplines e.g. electronics, electro-optical device physics and opto-mechanics.Extensive knowledge in materials and component selection.Requirements Engineering and Trade offsElectro-Opto-mechanical Design and AnalysisIntegration of Optical SystemsValidation and Verification Engineering, including testingThe ability to review and critique optical systems, balancing technical requirements withprogrammatic and budget constraints.Knowledge of Quality Management mechanisms, failure reviews and investigation analysis ispreferred.Good team player; able to work in a close-knit teams with design, analysis, integration and testengineers is mandatory.Minimum QualificationsMS/PhD in Applied Optics or Physics with a concentration in optics is preferred.Basic Opto-Mechanical knowledge to aid in optical system development.Optical design experience with proficiency in ZEMAX, CODE V and or other equivalent designpackage.Staff Mechanical Design EngineerLocation: Florida
  6. 6. The Staff Design Engineer, performs a variety of engineering assignments utilizing a wide rangeof engineering principles including micro-electronics, MEMS, nano-particles, and microfluidics.Works at an advanced technical expertise level involving planning development and design ofequipment/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 engineering vendors from beginningof design process through feasibility and start-up processes.Acts as advocate for continuous improvement of technology and processes.Plans, conducts and directs research, development or engineering assignments.Manages multiple projects across various disciplines.Project management at outside 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 equipment and/or process enhancements that will improve productquality and yield, process sustainability and efficiency, and safety.Education and Experience:An MS in Engineering/Material/Natural/Physical Science or equivalent along with 7 years ofexperience in design, project management and sciencePhD in Engineering/Material/Natural/PhysicalScience or equivalent with 5 years of experience indesign, project management and science. A degree in Design Engineering is preferred.Thorough knowledge and complete understanding and application of principles, concepts andpractices of Mechanical Design, preferably in the field of medical devices are required.
  7. 7. Product development experience is required.Expertise in SolidWorks or equivalent is required.Experience designing products with Ergonomics and Form Factors in mind are preferred.Experience designing hand held devices is preferred.Excellent written and oral communication skills are required.Travel of up to 10% Domestic and International is required.Optical EngineerLocation: FloridaThe Optical Engineer will provide Engineering expertise on the mechanical design, analysis,manufacturing, and assembly of optical systems. The position will also include selection,interaction, and the lead role in working with key external partners. Key responsibilities include:Performing metrology system research and development, managing external partners in designefforts, and Developing Commercialization Requirements for Optical Systems. The successfulcandidate must show initiative and will be a part of an interdisciplinary team involving analysts,designers, and engineers in the development of optical systems for use in a productionenvironment.This position will require a minimum of a BS Degree with 4 years of relevant experience, OR aMS degree with 2 years of relevant experience OR a PhD with relevant areas of study orexperience.Candidates who possess a degree in Physics, Mechanical or Optical Engineering are highlypreferred.Knowledge of optical mounts, bonds, kinematic principles, materials, and understanding of theimpact of environmental influences on optical system performance preferred.A background in design, analysis and the ability to work in a collaborative environment is highlydesired.This position requires the ability to be able to work with interdisciplinary teams and clearlydescribe results in oral presentations and written reports.
  8. 8. Experience with ZEMAX or ASAP programs preferred.A working knowledge of optical systems performance metrics is required.Experience in the specification, fabrication, and sourcing of customized optical components ispreferred.Experience in development of compact and lightweight packaging of optical systems ispreferred.Proficient with AutoCAD, Pro Engineer, or SolidWorks.US Citizenship or Permanent Resident status requiredStaff Engineer - Optical MetrologyLocation: FloridaAccountable for methodologies to test new and existing product characteristics and performance.Methodology development includes the construction, validation, documentation and support ofall optical and dimensional test methods.Works with product development teams to transfer design requirements into test methods.Champions optical design and engineering layouts for new system ideas.Manages hardware acquisition efforts, working with suppliers to create new systems withinbudgetary and schedule constraints.Monitors industry trends for opportunities to develop new testing methodologies.Provides optical consulting to material development teams.Contributes to the development of long-term strategies for upgrading and expanding metrologycapabilities.Development of optical and dimensional test methods.Analysis of existing and competitor product performance.Initiates system quality improvements.
  9. 9. Qualifications:Optics, Physics, Engineering or equivalent technical degree with 5years experience working inindustry.Development of test methods is required.Analysis of existing and competitor product performance is an asset.Keeping abreast of new technology and practices through periodicals, networking and strategicinteraction with peers is an asset for this position.Initiates system quality improvements is an asset along with Optical consulting experience.Experience in optical mechanics is an asset. Having technical leadership is required in thisposition.Having experience in the analysis of measured data is also required in this role.Experience in managing external vendors is preferred.Knowledge of calibrations and metrology is required for this position.Verification and Validation through testing is required.Principal Optical EngineerLocation: MassachusettsLooking for a Principal Optical Engineer to provide leadership in the design, manufacturing, andtest of new products involving optical systems for metrology applications as well as opticalsystems for image sensors.The successful candidate will lead the specification, design, development and deployment ofoptical based metrology systems, and design and implementation of critical calibration fixturesand devices used in the production of these systems. This individual will also design, develop,and deploy optical systems used for low cost, embedded machine vision sensors and systems.Essential Functions:
  10. 10. Lead / consult on the design and implementation of high precision, low-cost opto-mechanicalsubsystems involving lasers, optics, and imaging sensors for industrial machine vision products.Work together with other mechanical and electrical development engineers to produceprototypes, pre-production units, and final products.Work with the development team leadership and NPI teams to implement DFM, DFA andmanufacturing process design for the optical systems under development.Specify and lead the design and construction of high precision fixtures, calibration stations andother high precision stations needed to produce 1K-10K units per years. Work withmanufacturing team to implement fixtures and efficient supporting processes.Work with NPI team to identify and coordinate suppliers world-wide to source high precision,low cost opto-mechanical & laser components for production of 1K-10K machine vision systemsper year. Work with suppliers to specify and construct tooling for components.Construct, track, and help drive project schedules for above responsibilities. Provide scheduleupdates, risk assessments, etc. to both Engineering and NPI teams.Required Knowledge, Skills, and Abilities:5-10 years demonstrated success at the specification, design, development and deployment ofoptically-based metrology products (preference for industrial systems), and on test develop5-10 years demonstrated experience in specification, design, development, and manufacturingtest development on industrial, electro-mechanical products.Results Driven, excellent communicator, attention to detail, fact based, and fast acting.BS from a top engineering school in EE, MechE or equivalent8+ years experience in relevant, high-tech, optical products in volume production.Helpful Knowledge, Skills, and Abilities:Experience with laser based systems a definite asset.Preference for experience with industrial optical products used for metrology.MechE training or experience.Experience with machine vision metrology productsExperience with embedded systems.
  11. 11. Experience with SolidworksOpto-Mechanical EngineerLocation: Washington D.C.Job Summary:Exciting opportunity for anOpto-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.
  12. 12. 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 sourcedcomponentsSee Other Positions: http://www.linkedin.com/in/keithleveneRegards,Keith Levenekeith@photonicsgrp.com

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