Description

• Support remediation assessment teams with the evaluation of risk documentation and post market record review (PIR, CAPA, past Field Actions (as applicable)
• Lead or mentors the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification, Reliability and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIR
• Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate
• Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors
• Influences cross-functional plans, guides overall project strategy, knows when to solicit feedback, and facilitate project decisions
• Builds quality into all aspects of work by maintaining compliance to all quality requirements, defending work of their team, as well as supports internal external regulatory audits
• Supports functional and divisional design quality goals and priorities

 
What we're looking for in you:
Required qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline
• 5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience
• Understanding of electrical safety standards IEC 60601
• Experience with reliability testing
• Demonstrated use of Quality tools/methodologies
• Strong written/verbal communication skills.
• Risk documentation per ISO14971

 
Preferred qualifications:

• Experience with class III medical devices
• BS in Electrical Engineering
• Previous R&D experience
• Strong knowledge of QSR and ISO standards
• Medical device experience
• ASQ certification

Key Skills

Education

Bachelor's degree