What are the responsibilities and job description for the Staff Design Quality Engineer position at Cynet Systems?
We are looking for Staff Design Quality Engineer for our client in Marlborough, MA
Job Title: Staff Design Quality Engineer
Job Type: Contract
Job Overview:
Pay Range: $55.94hr - $59.44hr
- 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:
- ASQ Certification preferred.
- Regulatory Affairs Certification (RAC) preferred.
Salary : $56 - $59