Senior Engineer - Design Assurance

As a Senior Engineer - Design Assurance, you'll play a key role in supporting the development of medical devices and drug-device combination products, helping ensure products are developed to the right levels of quality, safety and regulatory compliance.

You'll take ownership of Design Control and Risk Management activities, working closely with cross-functional project teams to solve problems, deliver key project milestones and ensure robust design assurance throughout the development lifecycle.

This is an opportunity to bring both your technical expertise and your judgement to a collaborative environment where you can influence projects, improve how we work and support the development of others within the team.

• Lead Design Assurance activities within cross-functional development projects, taking ownership of activities, deliverables and key milestones.
• Lead the creation, approval and ongoing management of Device Development records in accordance with internal procedures and applicable regulatory requirements.
• Apply Design Control and Risk Management principles throughout the medical device and/or drug-device combination product development lifecycle.
• Develop and improve internal processes and procedures, ensuring continued alignment with applicable regulations, standards and guidance.
• Act as a Subject Matter Expert in relevant Design Assurance processes, regulations and standards.
• Represent Design Assurance and Device Development during cross-functional project and company activities.
• Support internal and external audits, including interactions with notified bodies and regulatory authorities.
• Communicate technical information, data, risks and recommendations clearly to project teams and senior leadership.
• Manage or coordinate internal and external testing resources where required.
• Mentor and provide technical and project support to more junior members of the Design Assurance team.
• Where appropriate, develop and manage project plans for smaller standalone projects or workstreams within wider programmes.

Cambridge, Cambridgeshire

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.