Senior Design Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Summary :

We are looking a Senior Design Quality Engineer to support quality assurance activities for electromechanical medical devices and combination products, including infusion systems and drug-device delivery platforms. This role works closely with R&D, Manufacturing, and Regulatory teams to ensure products are developed and manufactured in compliance with medical device quality and regulatory requirements.

This is a hands-on quality engineering role focused on design controls, verification & validation, risk management, and product lifecycle quality support.

Roles & Responsibilities:

• Support quality activities across the product lifecycle for electromechanical and combination medical devices.
• Apply Design Controls (21 CFR 820.30 / ISO 13485) during product development.
• Review and approve design inputs/outputs, test protocols, and validation reports.
• Support design verification and validation testing for mechanical, electrical, and software-controlled systems.
• Participate in risk management activities (FMEA, hazard analysis, risk reviews).
• Ensure traceability from user needs requirements verification validation.
• Support change control and engineering change assessments.
• Investigate quality issues and support root cause analysis and CAPA.
• Review DHF/DMR documentation for completeness and compliance.
• Partner with engineering and manufacturing teams to ensure quality is built into product design.
• Support supplier quality activities for critical components.
• Contribute to regulatory submission documentation as needed.

Education & Experience :

• Bachelor's and Master's degree in Mechanical, Electrical, Biomedical, or related Engineering field.
• 8+ years Quality Engineering or Quality Assurance experience in medical devices.
• Hands-on experience with electromechanical medical devices.
• Strong working knowledge of:
• Design Controls.
• Risk Management (ISO 14971).
• ISO 13485 / FDA 21 CFR 820.
• Experience supporting verification & validation testing.
• Experience with DHF documentation and change control.
• Experience performing investigations and CAPA.
• Ability to work cross-functionally with engineering teams.

Preferred:

• Experience with infusion pumps or drug delivery systems.
• Combination product experience.
• Knowledge of IEC 60601, IEC 62304, or IEC 62366.
• Experience supporting 510(k) or other regulatory submissions.
• ASQ CQE / CQA certification.
• Experience with eQMS systems.

Apply Online