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.
Required qualifications:
- 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%.
Preferred qualifications:
- Minimum of 3 years experience in medical device engineering.
- Proficiency with Minitab or equivalent statistical analysis software.
- Six Sigma certification.
- 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.
Featured benefits
Medical insurance, Vision insurance, Dental insurance, 401(k)