Senior/Principal Systems Design Quality Assurance Engineer -Medical Device #1425
ECI · Arden Hills, MN, USA ·
- Seniority
- Principal
- Category
- QA
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the role
As a Sr. Design Quality Assurance Engineer, you will ensure that all requirements are met for the Product Lifecycle Process, Risk Management, Design Controls, and Usability Testing. You will work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.
- The integration assessment/review phase has been completed and the team is now moving into execution.
- A significant amount of DFMEA work is required, including building new DFMEAs from scratch as design inputs, outputs and EDOs continue to evolve.
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- Focused on a changing implantable system involving software, firmware, electrical, and external system components.
- Will support:
- Design History File Review
- Involved in Design reviews
- Design Verification (DV) reviews
- TMV reviews
- Design Change Assessments (DCAs)
- Ownership of DFMEA activities
- Experience with BSC Cockpit is highly preferred.
- Hazard Analysis experience is not the primary focus for this position.
- Active implantable medical devices
- System-level design assurance
- DFMEA development and risk management
- Design controls and DHF remediation
- Firmware, software, and electrical systems exposure
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.