Sr. Design Quality Engineer

Responsibilities

• Serve as the primary quality representative within cross-functional product development teams, ensuring adherence to regulatory requirements and quality best practices.
• Lead quality deliverables such as Project Design & Development Plans, Field Assessment Plans, Design Changes, and Design & Usability Validation Plans. Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety.
• Lead Risk Management activities and documentation throughout the design process.
• Function as a project leader or specialized technical team lead with cross‑functional impact, including division-level representation on cross‑divisional quality system initiatives.
• Apply systematic problem‑solving tools such as 5 Whys, Is‑Is Not, DMAIC, and Six Sigma to drive root cause identification and corrective actions.
• Mentor and coach engineers in quality engineering principles and problem‑solving methodologies to promote a culture of learning and continuous improvement.
• Communicate quality priorities and recommendations to stakeholders across departments, using influence and negotiation to integrate quality into strategic decisions.
• Identify and implement improvements to quality systems and practices, championing best‑in‑class standards.
• Act as a subject matter expert during internal and external regulatory audits; support audit responses and submissions through high‑quality technical writing.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• Minimum of 5 years' experience in medical device engineering.
• Detailed understanding of U.S. and international regulatory requirements including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971.
• Ability to travel approximately 10–20%.

• Minimum of 3 years experience in medical device engineering.
• Proficiency with Minitab or equivalent statistical analysis software.
• Strong expertise in design controls, quality engineering, risk management, and technical problem‑solving.
• Excellent communication and interpersonal skills with proven ability to influence teams and leadership.
• Demonstrated leadership and mentoring capabilities in a quality‑driven environment.
• Strategic mindset with the ability to manage hands‑on project needs and long‑term initiatives.

Mid‑Senior level

Full‑time

Quality Assurance, Engineering, and Design

Medical Equipment Manufacturing

• Medical insurance
• Vision insurance
• 401(k)