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We are looking for Staff Design Quality Engineer for our client in Marlborough, MA
Job Title: Staff Design Quality Engineer
Job Location: Marlborough, MA
Job Type: Contract
Job Overview:
Pay Range: $55.94hr - $59.44hr
We are looking for Staff Design Quality Engineer for our client in Marlborough, MA
Job Title: Staff Design Quality Engineer
Job Location: Marlborough, MA
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.
- 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 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.
- 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.
- 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.
- 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.
- Bachelor s degree in Engineering, Life Sciences, or related technical field required.
- Advanced degree strongly preferred.
- ASQ Certification preferred.
- Regulatory Affairs Certification (RAC) preferred.
Salary : $56 - $59