Staff Design Quality Engineer

• 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

• 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.

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