Design Quality Engineer- Medical Device

Overview

The Design Quality Engineer ensures that all medical device design and development activities meet safety, performance, and regulatory standards. This role partners with cross-functional teams to support new product development and sustaining engineering projects, driving quality, compliance, and risk management throughout the design lifecycle.

An innovative medical technology manufacturer specializing in complex electromechanical devices designed to enhance patient care and clinical outcomes. The company focuses on developing life-sustaining systems that combine engineering precision, biological science, and rigorous quality standards within a highly regulated environment.

Base pay range

$110,000.00 / yr - $120,000.00 / yr

Key Responsibilities as Design QE

• Ensure design controls align with corporate, customer, and regulatory QMS requirements.
• Partner with R&D, Manufacturing, Regulatory, and Project Management teams across the full product lifecycle.
• Provide quality input on product requirements, specifications, and critical-to-quality parameters.
• Support design verification and validation activities including test protocols, reports, and issue resolution.
• Lead and maintain design risk management activities (FMEAs, risk controls, verification of effectiveness).
• Participate in design reviews, maintain the Design History File, and support Design Transfer.
• Contribute to regulatory submissions, audits, and CAPA investigations.
• Drive continuous improvement of quality processes and SOPs.

Profile / Qualifications

Why Join

Additional Information

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Location notes and other job details are based on current postings and may be updated.

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