Design Quality Engineer

Katalyst Healthcares and Life Sciences

Boston, MA

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.
bility to collaborate effectively across technical and cross-functional teams.
bility to balance multiple priorities and manage projects independently.
Strong technical and/or project leadership experience

Preferred Qualifications:

dvanced 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.
dvanced degree preferred.

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Vacancy posted 5 days ago

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