1. 1409 Superior Ave, Unit O
Newport Beach, CA 92663
Cell: (808) 217-5319
e-mail: rjtandler@hotmail.com
RobertJ.TandlerJr.
Education Bachelor of Science, Mechanical Engineering, University of California, Irvine
Experienc
e
August, 2013 – Present Cochin, India
JJ Orthodontics
Engineering Consultant
Advising on creating new implant manufacturing facility in India. Modeling and
blueprinting complete dental implant system in SolidWorks 2015 including implant
components and instrumentation. Plastic and injection molded parts design. Sterile
packaging design, test and manufacture per ASTM & ISO standards. Creating GMP
required documentation for production. Generating and executing design verification
activities and validation plans. Negotiating the sale of Intellectual Property for novel
orthodontic bracket system.
July, 2013 – Present San Clemente, CA
PC Engineering
Engineering Consultant
Designing innovative orthodontic bracket, sourcing vendors, negotiating patent rights.
October, 2013 – March, 2014 Newport Beach, CA
Blue Sky Bio
Engineering Consultant
Engineered dental implant products for strategic marketing purposes. SolidWorks 3D
Modeling and blueprint drafting on new implant line extension.
March, 2010 – July, 2012 Newport Beach, CA
Glidewell Laboratories
Program Manager
Responsible manager and cognizant engineer for designing, developing and
manufacturing 2 complete dental implant systems and associated packaging and
instrumentation. Directed all engineering, regulatory, purchasing, manufacturing, quality
assurance and marketing activities necessary to introduce new implant product lines
and obtain FDA 510(k) clearances. Modeled and drafted complete dental implant
system in SolidWorks. Plastic and injection molded parts design. Created GMP required
documentation for production. Generated and executed design verification activities and
validation plans.
January, 2009 – Present Buenos Aires, Argentina
Odontit
Engineering Consultant
Developing mechanical test protocols per ISO standards. Creating new dental implant
2. systems and revising blueprints on existing product lines. Directing draftsperson on
formal blueprinting and documentation. Advising vendors on manufacturing processes.
Consulting on R&D test methodology.
April, 2007 – November, 2007 Pearl Harbor, HI
Raytheon
Team Leader (position required active Secret Clearance)
Lead a team of technicians in the final assembly and test of undersea weapons.
Responsible for training, developing and performance management of the team.
Responsible for the adherence to schedule, procedural compliance and quality
performance of the assembly teams. Performed activities in a variety of cross-functional
areas including safety, production planning and control, quality, equipment and material
management.
December, 2004 – April, 2007 Keaau, HI
Self-Employed
Project Manager/Owner Builder
Completed construction of my two story residence. Actively participated in all phases of
building from design and permits to finish carpentry and landscaping. Personally
handled all purchasing, accounting and negotiated sub-contracts and financing.
September, 2003 – November, 2004 Palm Beach Gardens, FL
Implant Innovations Inc (3i is a subsidiary of Biomet)
Project Manager
Managed multiple activities to bring new products to market in accordance with internal
and current Federal regulations. Provided leadership and mutual accountability to core
team and cross-functional teams supporting projects. Personally surveyed and
documented feedback from leading implantologists on proposed new products for
Marketing evaluation. Planned and assigned responsibilities and resources to achieve
project goals. Executed and maintained approved project schedules to obtain
deliverables (Design History Files) and milestone product release dates. Chaired critical
meetings including Design Reviews, Risk Analyses and team meetings. Developed new
procedures for product development. Approved design change control documentation
and change order requests according to procedures.
August, 2001 – May, 2003 Yorba Linda, CA
Nobel Biocare
Project Engineer
Directly responsible for research, design, development and launch of state of the art
implant and prosthetic devices for the largest dental implant company in the world.
Released extremely profitable new product lines. Worked directly with clinicians to
improve existing products. Simplified and reduced number of complex components and
assemblies necessary to inventory. Accomplished the successful scheduling,
manufacturing, purchasing and inspection of new parts. Employed the use of innovative
processes, materials and biocompatible coatings. Relied upon to resolve Regulatory
Affairs issues, customer complaints and corrective actions. Dispositioned discrepant
parts. Conducted biological, mechanical and spectroscopic testing. Completed
validations and test reports in accordance with FDA CFR’s and ISO guidelines.
3. 1992 - 2003 HI and CA
Engineering Consultant
Various independent contract jobs worked concurrently with positions listed on this
resume. Advised on engineering and regulatory issues, mechanical testing, 510(k)
submissions, design and development, etc. (client list available).
1997 - 1999 San Juan Capistrano, CA
Tronomed (acquired by Tyco, Intl)
Sr. Project Engineer
Developed medical interconnect products and systems in the GMP regulated and ISO
certified environment. Supported sales and marketing with detailed engineering quotes
including product cost, manufacturing process and lead-times. Interfaced directly with
prospective customers and vendors to refine the product definition and to ensure the
cost and lead-time goals. Selected vendors and sourced components. Built, tested and
troubleshot prototypes for product verification. Validated manufacturing process while
ensuring acceptable yields and smooth transition to production.
1993 – 1995 & 1997 Irvine, CA
Interpore International (subsidiary of Biomet)
Project Engineer
Successfully designed, developed and released for sale complete dental implant line
including over 200 high precision components. Selected and qualified domestic vendors
for cost effective price and delivery. Created and formally documented complete GMP
system with blueprints, Standard Operating Procedures, Device Master Records,
Design History Records, etc. Acted as liaison between consulting physicians and the
company while testing new products. Resolved customer complaint issues. Reduced
manufacturing costs and released innovative products to market, significantly increasing
sales. Initiated and executed validation reports for manufacturing equipment, processes
and systems.
Skills
Proficiency in the use of SolidWorks (3D modeling & drawing), MS Office, MRP systems
(e.g. SAP, Oracle, etc.). Basic knowledge of Spanish and French. Hands-on knowledge
of precision machining and blueprint drafting, Geometric Dimensioning and
Tolerancing per ASME Y14.5, Lean Manufacturing.