Senior Design Quality Engineer

The Senior Design Quality Engineer is responsible for ensuring quality is embedded throughout the product development lifecycle, from concept through commercialization and post-market support. This role partners closely with cross-functional teams to ensure products meet regulatory requirements, internal quality standards, and customer expectations.

• Fast-Growing, Innovation-Focused Medical Device Company
• Excellent Benefits including 100% Medical coverage for indiv and family, The key responsibilities of the Senior Design Quality Engineer are:
• Serve as the Quality representative on cross-functional product development teams.
• Ensure compliance with design control procedures (e.g., FDA 21 CFR Part 820, ISO 13485).
• Review and approve design documentation, including design inputs, outputs, verification, validation, and design transfer activities.
• Support the development and maintenance of Design History Files.
• Lead and support risk management activities in accordance with ISO 13485:2016, 21 CFR Part 820 and MDSAP
• Facilitate risk assessments including FMEA/FMECA, hazard analyses, and risk/benefit evaluations.
• Ensure risk controls are effectively implemented, verified, and documented
• Collaborate with Manufacturing and Operations to ensure smooth design transfer and process readiness.
• Review production specifications, process validations, and inspection criteria.
• Support process validation activities and ensure quality requirements are maintained in production.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field (Master’s preferred).
• 5+ years of experience in Design Quality, Quality Engineering, or related roles within the medical device industry.
• Strong knowledge of design controls and product development processes.
• Deep understanding of ISO 13485 requirements.
• Experience with risk management standards (ISO 14971).
• Familiarity with verification & validation methodologies and statistical analysis tools.
• Experience with CAPA systems, change control, and document management systems.

My client is driven by a mission rooted in innovation, transparency, and patient benefit, the company emphasizes excellence in design, adherence to global regulatory standards, and the development of a collaborative, talent-focused workplace. With continued investment, substantial venture backing, and ongoing expansion of its technology platform, the organization remains at the forefront of advancing next-generation treatment solutions for chronic heart failure