Design Quality Engineer

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.