Michael Page
Design Quality Engineer- Medical Device
Michael Page, Lowell, Massachusetts, United States, 01856
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
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. 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. 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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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
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. 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. 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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