Senior Design Quality Engineer

A Day in the Life

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Capable of mentoring junior quality engineers in providing quality engineering support.

• Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Hands on experience with tools package release process for both Software Hardware tools/accessories
• Review non product/off-the shelf tools for products
• Experience in software or hardware design transfer process for tools or products
• Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, FDA Quality System Regulations, EU MDR and inhouse Standards.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Handson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA
• Ensure successful transfer of new products/tools to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Participate when appropriate in audits
• Ensures applicability to SOUP / OTS validations in the product development
• Participate and provide input to training on department / procedures and policies
• Hands-on experience on Software Risk Management, Design Controls. Develop templates and training based on the quality system regulations, applicable standards and guidance.
• Independently reviews all SW deliverables to ensure compliance with development process and the standard.
• Deliver presentations to the QA organization on status and issues of assigned projects. Deliver training to departments outside of QA.
• Previous experience working in a cross-functional team environment.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues
• Provide support to the Regulatory Department in writing technical submissions.

• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics) Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills including protocol / report development and technical presentations.
• Strong in software design and development, software verification and validation activities
• Computer literate and experience with PCs, networks, applications, software development life cycle Travel may be required
• Knowledge in cybersecurity

• Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Comparative Statistical techniques, sampling plans, GRR, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis. Familiar with DMAIC or DMADV(DFSS) methodologies