Senior Medical Device Engineer

We have a need for Senior Medical Device Engineer. The team is currently in stage two of new product development where we are finalizing the product design.

This is a FTE onsite role.

We are looking for candidates that must have:

Must have experience with Keyence Measurement System software

The ability to conduct test method validation and FMEA at a high level

Proven track record of performing data analysis (the group uses Minitab)

Must be able to adapt to the days needs and work within a clean room.

Day to day may include but is not limited to managing receiving inspections assessing risk (w/ FMEA) and developing inspections methods on top of other team tasks.

The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints.

Job Responsibilities:

Lead identification development and optimization of complex Manufacturing processes using engineering methods (e.g. Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities & implement solutions for redesign/design of complex equipment new technologies (including automation and software) tools fixtures etc. to improve manufacturing processes and reduce overall process/product risk profile.

Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create validate and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/methods based on engineering principles; ensure completion of comprehensive process validations (IQ/OQ/PQ) including analyzing results and developing reports; collaborate with crossfunctional team members to facilitate project success and ontime completion

Develop technical content of risk management files

Lead in the investigation of complex manufacturing product quality and compliance issues (e.g. SCAR CAPA nonconformances audit observations) for all supplier production processes and based on engineering principles; analyze results make recommendations and develop reports

Education/Experience:

Bachelors degree in engineering required.

57 years experience required.