Design Quality Engineer- Medical Device

About Our Client

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.

Job Description

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.

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.

The Successful Applicant

Minimum Qualifications

• Bachelor's degree in a technical or engineering field.
• 3-5 years of experience in the medical device or regulated manufacturing industry.
• Strong understanding of design control, risk management, and regulatory frameworks (FDA, ISO 13485, ISO 14971, EU MDR).
• Hands-on experience with electromechanical systems and system-level design.
• Proven ability to manage multiple projects in a fast-paced, cross-functional environment.

What's on Offer

Why Join

• Opportunity to work on cutting-edge medical technology that saves lives.
• Collaborative, innovation-driven environment.
• Competitive compensation and comprehensive benefits.
• Strong company culture centered on teamwork, integrity, and continuous improvement.

Contact

Bridget Petti

Quote job ref

JN-102025-6860863