Medical Device Design Quality Engineer
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Role details
Tech stack
Job description
- Support design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.
- Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments to identify and mitigate design and manufacturing risks.
- Review protocols and participate in V&V planning to ensure alignment with product requirements and risk controls.
- Support design transfer activities by ensuring product and process requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.
- Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs). What’s Needed?
Requirements
Our client, a leading organization in the medical device industry, is seeking a Medical Device Design Quality Engineer to join their team. As a Medical Device Design Quality Engineer, you will be part of the Quality Assurance department supporting product development and manufacturing teams. The ideal candidate will demonstrate strong analytical skills, attention to detail, and a proactive mindset, which will align successfully in the organization., + Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred).
- 3+ years of experience in medical device quality engineering or a related field.
- Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
- Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
- Proficiency in statistical analysis tools (Minitab) and problem-solving methodologies (8D, DMAIC).
Benefits & conditions
- Opportunity to work in a dynamic and innovative environment.
- Immediate start with potential for long-term career growth.
- Collaborate with a dedicated team of professionals in the medical device industry.
- Engage in meaningful work that impacts patient safety and healthcare advancements.
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Supportive work culture emphasizing continuous improvement and professional development. Upon completion of waiting period consultants are eligible for:
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account
- Health Flexible Spending Account
- Dependent Care Flexible Spending Account
- Supplemental Life Insurance
- Short Term and Long Term Disability Insurance
- Business Travel Insurance
- 401(k), Plus Match
- Weekly Pay If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! About ManpowerGroup, Parent Company of: Manpower, Experis and Talent Solutions. Experis® is a global leader in technology services and part of the ManpowerGroup® (NYSE: MAN) family of brands. We connect skilled technology professionals with meaningful opportunities where they can grow their careers, expand their expertise and make a real impact. Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology, Experis helps people gain experience with leading organizations, build sought-after skills and take the next step toward a brighter future. Backed by ManpowerGroup’s 75+ years of workforce expertise and global reach across more than 70 countries and territories, Experis brings the scale, insight and opportunity to help people and businesses thrive. ManpowerGroup is consistently recognized for its commitment to inclusion, ethics and responsible business, including being named one of the World’s Most Ethical Companies. Learn more at Experis.com.
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