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# Staff Design Quality Engineer

- **Company:** CYNET SYSTEMS INC.
- **Location:** Marlborough, MA, United States
- **Experience:** Expert
- **Salary:** $116,355.0 - $123,635.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Data Analysis
- **Published:** May 17, 2026
- **Apply:** https://www.careerjet.com/jobad/us431f85218ef4c91928f572f61e8481a4

## About the Role

* Bachelor's degree required.
 * 8+ years of experience in medical device design and development with strong focus on design control and risk management.
 * Strong knowledge of FDA regulations and quality management systems (FDA 21 CFR Part 820, ISO 13485, ISO 14971, IVDR 2017/746).
 * Experience working in FDA-regulated environments.
 * Strong understanding of design control processes and risk management principles.
 * Excellent communication and stakeholder management skills.
 * Strong analytical and problem-solving abilities.
 * Ability to work in a matrix organization.

Experience:

 * Experience in medical device or IVD product development.
 * Experience supporting audits, CAPA, non-conformance investigations, and regulatory submissions.
 * Experience managing design history files and quality systems., * Experience with regulatory submissions and post-market surveillance.
 * Experience applying standards such as IEC 62304, CAP, CLIA, and related regulations.
 * ASQ Certification preferred.
 * Regulatory Affairs Certification (RAC) preferred.

Skills:

 * Design control and risk management.
 * Quality management systems.
 * Regulatory compliance (FDA, ISO, IVDR).
 * Audit and CAPA management.
 * Data analysis and quality metrics tracking.
 * Technical documentation and reporting.
 * Cross-functional collaboration and leadership.

Qualification And Education:

 * Bachelor's degree required in Engineering, Life Sciences, or related field.

## Description

* The role involves leading design quality engineering activities for IVD medical devices, ensuring compliance with global regulatory standards, driving design control, risk management, supplier quality, and post-market surveillance activities across the product lifecycle., * Develop, implement, and maintain quality systems and processes compliant with FDA, ISO, IVDR, and related standards for IVD products.
 * Conduct hazard analysis and risk assessments throughout the product lifecycle.
 * Lead internal and external audits, including preparation, execution, and follow-up activities.
 * Manage CAPA processes, non-conformance investigations, and deviations.
 * Collaborate with cross-functional teams to integrate quality requirements into design control, verification, and validation activities.
 * Review and approve design control documentation including design inputs, outputs, verification/validation protocols, and reports.
 * Establish and maintain Design History Files for IVD products.
 * Assess and qualify suppliers across product lifecycle stages.
 * Monitor and analyze quality metrics and trends to drive improvements.
 * Support regulatory submissions and post-market surveillance activities.
 * Manage complaints, field actions, MDRs, and incident reporting activities.
 * Drive continuous improvement initiatives in design control and risk management processes.
 * Ensure compliance with evolving regulatory requirements and update internal procedures accordingly.
 * Follow corporate policies and perform additional assigned duties., Job Description: Saab Inc., Autonomous and Undersea Systems division is seeking an innovative and experienced Senior Staff Mechanical Engineer to implement product design require…
 + 21 hours ago


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