Senior/Principal Systems Design Quality Assurance Engineer -Medical Device #1425

ECI; Arden Hills (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

ECI in Minnesota is seeking a Sr. Design Quality Assurance Engineer to drive DFMEA, risk management and design controls across an implantable medical device program.

You'll work in cross-functional teams on hardware, firmware and software, supporting DHF remediation, DV reviews and DCAs to ensure regulatory compliance and product quality.

Qualifications

• Experience with DFMEA and risk management.
• Knowledge of design controls and remediation of design history files.
• Exposure to firmware, software and electrical system aspects.
• Experience with DHF reviews, design reviews, DV reviews and DCAs.
• Ability to work in cross-functional teams on implantable medical devices.

Responsibilities

• Lead DFMEA activities and develop DFMEAs from scratch.
• Support DHF reviews and participate in design reviews.
• Conduct DV and TMV reviews and assist with DCAs.
• Own DFMEA activities and ensure regulatory compliance and product quality.
• Collaborate with hardware, firmware and software teams on implantable systems.

Skills

DFMEA development

Risk management

Design controls

DHF remediation

Firmware/software/electrical systems

Cross-functional collaboration

Tools

BSC Cockpit

Job description

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.

Brief Description

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.

What You’ll Do

• 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.
  • 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.

What We Look For

• 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.