Bachelor's degree in a technical or scientific discipline required; Mechanical Engineering or Bioengineering preferred.
5+ years of experience in a highly regulated industry, particularly in medical devices or pharmaceuticals.
Design Quality Engineering and Design Control experience necessary.
Proven experience in conducting Design FMEA and Process FMEA activities.
Experience in process verification and/or validation is essential.
Strong problem-solving and decision-making skills are a must.
Effective written and verbal communication skills required.
Responsibilities
Support lifecycle management activities for existing sports medicine and soft tissue repair products.
Partner closely with cross-functional teams including design engineering, manufacturing, and regulatory affairs.
Facilitate compliant design and process changes per quality system requirements.
Conduct and support Design and Process Failure Mode Effects Analysis (FMEA) activities.
Support process verification and validation tasks to ensure quality standards.
Execute and document rigorous product testing activities.
Ensure adherence to proper change management practices.
Benefits
Opportunity to work in a fast-paced, regulated environment.
Collaborative work culture with diverse cross-functional teams.
Leadership roles within the quality system, enhancing professional growth.
Involvement in critical product lifecycle management for innovative healthcare solutions.
Full Job Description
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.
