Medical Device Design Assurance Engineer

SRG; Cambridge; On-site; GBP 42,000 - 66,000; Full time

Job summary

SRG in Cambridge is seeking a Design Assurance Engineer to ensure medical devices and drug delivery systems meet regulatory, quality, and design control requirements throughout development.

You will review DHFs, support risk management per ISO 14971, assist audits and regulatory submissions, and collaborate with cross-functional teams to drive robust verification, validation, and design decisions.

Qualifications

• Experience developing and delivering regulated medical devices.
• Strong understanding of Quality Management Systems and design controls.
• Experience with design verification and validation activities.

Responsibilities

• Support design assurance and product development activities.
• Review design control activities and maintain DHFs.
• Participate in ISO 14971 risk management and residual risk assessments.
• Assist with audits, regulatory submissions, and technical documentation.
• Collaborate with cross-functional teams to ensure traceability and compliance.

Skills

Detail-oriented

Quality-focused mindset

Stakeholder management

Communication skills

Report writing

Education

Degree in Mechanical Engineering

Biomedical Engineering or related field

Job description

SRG in Cambridge is seeking a Design Assurance Engineer to ensure medical devices and drug delivery systems meet regulatory, quality, and design control requirements throughout development.

You will review DHFs, support risk management per ISO 14971, assist audits and regulatory submissions, and collaborate with cross-functional teams to drive robust verification, validation, and design decisions.