Senior Medical Device Design Assurance Engineer

SRG; Cambridge; On-site; GBP 65,000 - 90,000; Full time

Job summary

SRG Cambridge is seeking a Senior Design Assurance Engineer to join a medical device organisation focused on next-generation drug delivery devices and combination products.

You will provide design assurance across the product development lifecycle, ensuring compliance with ISO 13485, ISO 14971, and 21 CFR Part 820 while collaborating with quality, regulatory and engineering teams to bring safe, compliant products to market.

Qualifications

• Experience developing medical devices in a regulated environment.
• Strong understanding of Quality Management Systems and quality engineering principles.

Responsibilities

• Review design control activities throughout the product development lifecycle.
• Participate in risk management activities in accordance with ISO 14971.
• Review engineering changes, impact assessments, and design modifications.
• Maintain Design History Files (DHFs) to a high standard.
• Support audits and regulatory submissions with Quality and Regulatory teams.
• Assist project teams in risk-based evaluation and traceability.

Skills

Quality engineering principles

Documentation skills

Cross-functional teamwork

Stakeholder management

Verification & Validation

Design controls

Risk management

Education

Degree in Mechanical Engineering, Biomedical Engineering, or related

Job description

SRG Cambridge is seeking a Senior Design Assurance Engineer to join a medical device organisation focused on next-generation drug delivery devices and combination products.

You will provide design assurance across the product development lifecycle, ensuring compliance with ISO 13485, ISO 14971, and 21 CFR Part 820 while collaborating with quality, regulatory and engineering teams to bring safe, compliant products to market.