Senior Quality Engineer (Medical Device Industry)

Excellent full-time opportunity with a growing and successfull organization

Requirements and duties:

1. Intimate knowledge of IEC 601-1 requirements.
2. Demonstrated knowledge of risk analysis and FMEA for hardware.
3. Able to develop test strategies from a risk analysis and FMEA.
4. Hands on working knowledge of electrical engineering.
5. Participate as a team member of a product development team. The engineer should also be able to lead the team if needed.
6. Assure that the team is in compliance with applicable procedures, standards and requirements. In particular, the engineer will assure that Design Control requirements are met and a complete and correct Design History File is compiled.
7. Complete all design verification testing, including data analyses, findings reconciliation, and final reporting.
8. Assist with design validations, including customer and lab visits.

Additional Requirements:

1. BS Degree in Electrical Engineering is required. An MS and /or MBA are desirable.
2. A minimum of five (5) years work experience as an Electrical Engineer in a product development setting is required.
3. Experience in the medical device field strongly recommended. Cardiology experience is a plus. Experience in other regulated industries such as aerospace or military defense will be considered.
4. Working knowledge of quality tools and statistics is required.
5. Problem solving skills are required.
6. Strong leadership skills are required.
7. Ability to work in a team setting is required.

8. Develop, evaluate and approve the product's performance and design specifications.
9. Provides QA tasks and timelines for the development plan, particularly the necessary Design Control elements of the QSR and division procedures are applied.
10. Participates in project Design Reviews. May act as independent reviewer