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Design Quality Engineer
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Overview
Job Description
- The Design Quality Engineer will support the Lifecycle Management organization responsible for maintaining existing medical device products across sports medicine and soft tissue repair. This individual will work cross-functionally with product design engineering, manufacturing, regulatory affairs, marketing, R&D, and quality teams to support design and process changes, perform risk management activities, execute product testing, and ensure appropriate change management practices are followed in compliance with design control requirements.
- The engineer will also provide leadership within the quality system, including corrective and preventive actions, nonconforming materials, risk management, process verification/validation, and medical device regulatory requirements. The ideal candidate will be self-motivated, collaborative, technically strong, and able to balance multiple priorities in a fast-paced, regulated environment.
Responsibilities:
- Support lifecycle management activities for existing sports medicine and soft tissue repair medical device products.
- Partner with design engineering, manufacturing, regulatory affairs, marketing, R&D, and quality teams.
- Support design changes and process changes in compliance with design control and quality system requirements.
- Conduct and support Design FMEA and Process FMEA activities.
- Support process verification and validation activities.
- Execute and document product testing activities.
- Ensure proper change management practices are followed.
- Support CAPA, nonconforming material investigations, risk management, and other quality system activities.
- Communicate effectively across quality, engineering, manufacturing, regulatory, and marketing teams.
- Manage multiple projects with varying levels of complexity, urgency, and cross-functional involvement.
- Troubleshoot roadblocks and drive tasks to completion with minimal oversight.
Requirements:
- Bachelor's degree in a technical or scientific discipline.
- 5+ years of experience in a highly regulated industry.
- Medical device and/or pharmaceutical industry experience.
- Design Quality Engineering experience.
- Design Control experience.
- Experience conducting Design FMEA and/or Process FMEA.
- Experience conducting process verification and/or process validation.
- Strong problem-solving and decision-making skills.
- Strong written and verbal communication skills.
- Ability to collaborate effectively across technical and cross-functional teams.
- Ability to balance multiple priorities and manage projects independently.
- Strong technical and/or project leadership experience
Preferred Qualifications:
- Advanced degree.
- Bachelor's degree in Mechanical Engineering or Bioengineering.
- New Product Development experience.
- Blueprint reading, inspection methods, and GD&T experience.
- Design Excellence, Six Sigma, or Lean experience.
- Spanish as a second language* strong bonus.
- Bachelor's degree required in a technical or scientific discipline.
- Mechanical Engineering or Bioengineering degree preferred.
- Advanced degree preferred.
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