Staff Design Quality Engineer

• The Staff Design Quality Engineer will serve as a senior design quality subject matter expert for complex IVD product development and lifecycle programs.
• The role involves providing authoritative design control oversight, guiding cross-functional teams on requirements and risk management, leading quality evaluation of design changes, and ensuring compliance with regulatory and quality system requirements across the product lifecycle.

Requirement/Must Have:

• 8+ years of progressive experience in design quality, development quality, or quality engineering within medical device or IVD environments.
• Strong expertise in design controls, risk management, verification/validation, design transfer, and lifecycle change control.
• Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and GMP requirements.
• Experience with complex IVD platforms, companion diagnostics, or software-enabled systems.
• Experience in multi-site or regulated manufacturing environments with high regulatory visibility.
• Ability to independently make and defend technical quality decisions using regulatory and scientific judgment.

Experience:

• Experience leading or supporting analytical and clinical validation programs.
• Experience with design reviews, traceability matrices, and design transfer packages.
• Experience supporting investigations, CAPAs, nonconformance assessments, and risk-based decisions.
• Experience working in cross-functional product development and lifecycle management environments.
• Experience supporting external partner or customer-facing development programs.
• Experience in audit and regulatory inspection support activities.

Responsibilities:

• Serve as senior design quality expert for complex IVD development programs.
• Review and approve design control deliverables including plans, requirements, risk files, and validation strategies.
• Guide translation of customer, clinical, manufacturing, and regulatory requirements into design inputs and outputs.
• Lead evaluation of design changes, platform updates, labeling changes, and transfer activities.
• Provide quality oversight for analytical and clinical validation programs.
• Lead or support complex investigations, CAPAs, and risk-based technical decisions.
• Drive improvements in design quality processes, templates, and governance systems.
• Support internal audits, regulatory inspections, and design governance forums.
• Mentor design quality and development personnel.
• Support management review through identification of quality risks and improvement opportunities.

Should Have:

• Experience in companion diagnostics or software-enabled diagnostic systems.
• Experience in pharmaceutical or external collaboration development programs.
• Lead auditor or advanced risk management training.
• Experience in multi-site IVD manufacturing environments.

Skills:

• Strong application of design controls and risk management principles.
• Strong technical and regulatory decision-making ability.
• Strong communication across technical and non-technical stakeholders.
• Strong documentation and writing skills.
• Ability to balance compliance, speed, and product quality.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to function in a matrix organization.
• Strong analytical, problem-solving, and project coordination skills.

Qualification And Education:

• Bachelor s degree in Engineering, Life Sciences, or related technical field required.
• Advanced degree strongly preferred.

License/Certifications: