Senior New Product Development DQA Engineer -Medical Device #2320

ECI; Arden Hills (MN); On-site; USD 100,000 - 150,000; Full time

Job summary

ECI in Minnesota is seeking a Senior NPD Design Quality Assurance Engineer to 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.

In this role, you will own DFMEA activities, review Design History File and participate in design

Qualifications

• DFMEA development and risk management.
• Design controls and DHF remediation.
• NPD/PDP project exposure preferred.
• Experience with design reviews and risk analysis.

Responsibilities

• Support DFMEA ownership throughout product development.
• Review Design History File and participate in design reviews.
• Contribute to Hazard Analysis where applicable.
• Perform Design Change Assessments (DCAs).
• Collaborate with cross-functional teams in NPD.

Skills

DFMEA development

Risk management

Design controls

DHF remediation

Design reviews

Hazard Analysis

BSC Cockpit

Tools

BSC Cockpit

Job description

About the role

As a Sr. NPD 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

• supporting products in the New Product Development (PDP Phase)


• Strong preference for candidates with an electrical engineering background.


• Biomedical engineering candidates are acceptable if they have a electrical foundation.


• A significant amount of DFMEA work is required, including building new DFMEAs from scratch as design inputs, outputs and EDOs continue to evolve.


• Will support:


• Design History File Review


• Involved in Design 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.

Required Experience:

• DFMEA development and risk management


• Design controls and DHF remediation

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.