This position works cross-functionally to lead research and development efforts of complex medical devices. The position designs, develops and implements new products, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.

Essential / Key Job Responsibilities (including supervisory and/or fiscal): 

Design: Designs, develops and implements new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Makes and presents engineering decisions. Participates and leads cross-functional teams in the design of a medical device. Contribute ideas and/or generate intellectual property submissions.

Process Development: develops new processesby understanding key process inputs and outputs, using statistic methods such as DOE as appropriate.Develops new process equipment and tooling, including specification development, vendor selection and negotiation.

Documentation: write and review product development plans, design reviews, technical documents and reports. Preparesand approves verification and validation protocols and reports.Develops and implements procedures/policy.

Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods. 

Testing: conduct engineering and competitor evaluations, and development unit testing.Plan, develop, executeand manage verification and validation activities for new products and processes.

Training: train technicians and engineers on new design and process development as well as new test methods. 

Supervisory/mentoring/coaching: Mentor/coach R&D technicians and engineers through New Product Development activities.May supervise or manage technicians, engineers or supervisors.

Fiscal: Creates, controls, manages a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.

Other Responsibilities may include, however are not limited to:

• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.

• Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.

Project Lead/Senior Engineer:

• Product Development: coordinates and/or directs all aspects of product development activity related to a product line, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with Operations and Supply Chain to deliver a new product to market in line with division and operational goals.

• Project Management: creates, tracks and meets project schedules, plans and budgets for the development of a new product (or line extension) and assesses priorities and makes assignments to direct reports to ensure project and company priorities are met. Coordinates with team members, internal and external suppliers and outside professionals to ensure project output meet users’ needs as well as applicable regulatory requirements.

• Design to Manufacturing Transfer: proposes and facilitates the selection of a new products manufacturing location. Coordinates and participates in the transfer of a new product to a manufacturing location(s) in conjunction with a manufacturing transfer lead.

Required Qualifications:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.

• Experience: 4-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus with 3-8years or Ph.D. degree with 0-3 years, medical device or equivalent industry experience).

• Demonstrated hands-on technical aptitude.

• Experience in design (DV&V) and process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.

• Ability to create and execute project plans.

• Ability to lead cross functional teams.

• Basic tooling, design and drafting knowledge.

• Excellent oral and written communication skills.

• Ability to analyze data, interpret results, and write reports. Proficient in statistic software.

• Training in Six Sigma or Design for Six Sigma.

Preferred Qualifications:

• Masters degree in relevant engineering discipline.

• Knowledge of cGMP and GLP is a plus.

Education and/or Experience:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.

• Experience: 4-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus with 3-8years or Ph.D. degree with 0-3 years, medical device or equivalent industry experience).