Staff Design Quality Engineer
- Act as the lead Quality Assurance representative on cross-functional new product development (NPD) teams
- Collaborate with technical experts in R&D, Process Development, Regulatory Affairs, Marketing, and Project Management to define design requirements and develop manufacturing processes for new product development
- Lead risk management activities and develop risk management plans and reports for product and process quality
- Create and maintain quality assurance documentation to support product development and regulatory submissions
- Identify and address gaps in design control processes and procedures
- Participate in design reviews to evaluate product risks and mitigation strategies
- Define and support design verification and validation test requirements and reports
- Promote efficient and statistically valid testing practices
- Support the definition of critical quality attributes and risk-based product evaluations
- Facilitate product design transfers to internal or external manufacturing
- Analyze feedback from early product launches and address quality issues
- Perform health risk assessments for post-market events
- Use tools such as FMEA, Root Cause Analysis, and GD&T for continuous improvement
- Interact with regulatory agencies and support audits and submissions
- Bachelor’s degree in science, engineering, or related discipline required
- MS, Certified Quality Engineer (CQE), or Certified Reliability Engineer (CRE) preferred
- Six Sigma Green or Black Belt preferred
- Minimum 5 years of experience in medical device or other regulated industries
- Knowledge of design and process verification and validation in product development
- Expertise with quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing
- Proficiency in reading and interpreting CAD drawings
- Experience with US and international medical device regulations and agency interactions (e.g., FDA, TUV, MoH)
- Strong foundation in quality concepts such as CAPA, audits, and statistics
- Ability to manage multiple projects in a matrixed organization
- Strong problem-solving, critical thinking, and communication skills
- Experience working in compliance and risk assessment scenarios
- Proficiency with Microsoft Office and statistical analysis tools (e.g., Minitab)
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company
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