Senior Engineer II - Quality Design & Reliability Assurance
$82,000–$113,000 year
On-sitePrinceton, New Jersey, United States or Cincinnati, Ohio, United States
Job Summary
Senior Engineer II in Quality Design & Reliability Assurance leads and supports design and development of medical devices, including software requirements and electrical/software architectures, with risk analysis (FMEAs/SHAs), DFSS and Lean improvement, and V&V/GR&R. Applies statistical methods to establish test plans and evaluate data; supports transfer to manufacturing; drives root-cause investigations and CAPA; maintains design control documentation (DHF, protocols, reports) and participates in internal/external audits. Collaborates with R&D, Regulatory, Manufacturing and Marketing to ensure compliant quality systems (ISO 14971, FDA QSR, ISO 13485) and supports line extensions, product/process transfers, and ongoing quality improvements.
Required Qualifications
- Bachelor’s degree in engineering
- 5 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP
- Strong analytical skills and a working knowledge of problem-solving methodologies
- Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques
- 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
- Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
- Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
- Demonstrates excellent organizational, verbal and written communication skills
- Proficient with the MS Office Suite, and statistical software
- Must be able to work independently with minimal supervision
- Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives
Desired Qualifications
- Bachelor’s degree in engineering
- 5 years of experience in medical device or other regulated industry
- Knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP
- Strong analytical skills
- Working knowledge of DFSS techniques, process improvement techniques, and Lean process improvement techniques
- Proficient with MS Office Suite and statistical software
- Ability to work independently with minimal supervision
- Experience leading design and development of medical devices
- Experience with risk analysis activities (FMEAs and SHAs)
- Experience with design verification/validation, GR&R, SPC
- Experience in transferring design to manufacturing
- Excellent written and verbal communication skills
- Project management and leadership abilities
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