Staff R&D Sustaining Engineer

The Staff Sustaining Engineer works independently to drive design changes on commercial products to improve upon performance, safety, compliance or cost. These changes include material changes, compliance to new testing standards, improvements to the product in order to address issues, implementing new test methods, supporting process improvement efforts, managing product line extensions or manufacturing transfers of critical components.

What you will do:

• Determine the testing required for design changes and will manage the execution. Assesses the patient risk appropriately for each design change
• Oversee product testing for design verification, design validation, shelf life, engineering studies and equivalency. Drafts protocols and reports as needed.
• Coordinate cross-functionally to implement design changes with Regulatory, Quality Assurance, Production, Manufacturing, and Supply Chain.
• Understands how product changes will be implemented into Production.
• Interfaces with physicians or Cath Lab personnel to investigate product complaints and obtain feedback on performance of devices. Investigates root cause of performance issues with complaints lab and manufacturing as needed.
• Supports Regulatory filings by providing expert technical input and responding to questions from Regulatory agencies.
• Provides guidance to product, operations and technology teams.
• Coordinates and documents project goals and progress and recommends appropriate revisions.
• Coaches others on engineering documentation and engineering principles
• Trains and/or provides work direction to technicians and less experienced engineers.
• Leads engineering teams to the successful completion of project goals
• Demonstrates knowledge of internal product and/or technology development processes through coaching and delivery of high quality, high impact deliverables.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

What you will need:

• B.S. in Engineering
• 4+ years experience
• Medical Device experience is a plus
• Expertise in two or more of the following areas: Design Control, Process Improvement, Quality Engineering, or Project Management would be great
• Sustaining experience is preferred
• Manufacturing Process knowledge in Nitinol Stent Manufacturing or Catheter Manufacturing is a nice to have
• Six Sigma or other Problem Solving methodology
• Experience in process development / process improvement
• Experience in Test Method Development and Design Verification and Validation a plus