Design Quality Engineer

Function

We’re looking for a Design Quality Engineer (DQE) to support our client’s growing R&D team as they make a pivotal shift into regulated medical device development. This is a high-impact role, ideal for someone with deep knowledge of regulatory frameworks who can drive compliance and elevate technical documentation standards across multidisciplinary teams. You'll play a central role in ensuring new product developments meet stringent international standards while enabling your peers to build safer, smarter medical solutions.

Your Role & Key Responsibilities

As a Design Quality Engineer, you’ll take ownership of the technical file strategy, guiding and collaborating across functions to ensure compliance with ISO 13485, IEC 62304, 510(k), and related regulatory requirements. You’ll work closely with project leaders, engineers, usability experts, and clinical teams to build documentation that stands up to audit and regulatory scrutiny.

Key responsibilities include:

• Leading the creation, review, and maintenance of technical documentation for medical device development.

• Coordinating cross-functional input from product management, software and security architects, verification & validation, and risk management.

• Acting as a regulatory coach to R&D, ensuring clear understanding and application of medical device standards across the team.

• Serving as the bridge between R&D and Quality/Regulatory Affairs to align expectations and responsibilities.

• Supporting internal and external audits by preparing robust, audit-ready documentation.

What You’ll Be Driving

In addition to core technical file responsibilities, this role will focus on building capability within the team and continuously improving processes:

• Mentoring team members on IEC 62304, usability engineering, risk management, and clinical evaluation practices.

• Identifying process gaps and collaborating across teams to improve compliance and documentation quality.

• Developing and delivering training sessions to embed regulatory awareness into day-to-day development activities.

• Shaping and executing regulatory strategies that align with global standards and project timelines.

Your Profile – What Makes You a Great Fit

To thrive in this role, you’ll bring a strong foundation in medical device quality systems and a collaborative, coaching-focused mindset. You’re someone who sees regulatory compliance not as a hurdle but as a critical part of innovation.

We’re looking for:

• Solid experience creating and managing technical files in the medical device industry.

• In-depth knowledge of ISO 13485, IEC 62304, 21 CFR Part 820 (510(k)), and related regulations.

• Experience with risk management, usability engineering, and clinical evaluation.

• Strong communication skills with the ability to translate complex regulatory requirements for cross-functional teams.

• Proven ability to mentor others and lead quality process improvements.

• Sharp attention to detail and analytical thinking to catch and correct gaps in compliance or documentation.