Sr Design Quality Engineer
$98,400–$147,600 year
On-site · Lafayette, Colorado, United States
Job Summary
Senior Design Quality Engineer responsible for leading quality activities across RPE within the ACM unit, driving product quality, reliability, and regulatory compliance through design controls, risk management, and cross-functional leadership. Key duties include reviewing designs for safety and regulatory impact (ISO 13485, EU MDR, FDA QSR 21 CFR 820), developing and maintaining risk management documentation (ISO 14971), supporting verification/validation plans and reports, sustaining engineering support across multiple domains, collaborating with R&D, Regulatory Affairs, Operations, Marketing and Program Management, applying DFSS/DFM methodologies to improve performance, and leading continuous improvement efforts in quality and manufacturing robustness; requires Bachelor’s Degree and 4+ years of quality experience, with preference for medical device/regulatory industry background and familiarity with relevant standards and quality systems.
Required Qualifications
- Bachelor’s Degree
- 4+ years of quality experience
- Experience in medical device industry or regulated industry
- Working knowledge of ISO 13485, FDA QSR 21 CFR 820, and EU MDR
- Experience applying ISO 14971 risk management
- Familiarity with IEC 60601 or medical electrical equipment standards
- Experience with design controls, verification and validation planning, and test execution for medical devices
- Experience with CAPA, root cause investigation, and failure analysis
- Technical experience with electronic hardware systems (PCB design, schematics, circuit analysis)
- Experience leading complex technical problems or cross-functional projects
- Strong written and verbal communication skills
- ASQ certifications (nice to have)
- Statistical methods experience (hypothesis testing, ANOVA, GR&R)
- Lean Six Sigma Green Belt or Black Belt (nice to have)
- U.S. work authorization sponsorship considerations for Principal level and above (context: sponsorship offered at Principal level+)
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.