Senior Product Engineer

Role location: Cambridge, UK

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by shaping the future of cancer care.

At Endomag, a Hologic company, we're redefining cancer treatment and empowering clinicians worldwide with innovative medical solutions.

We're now looking for a Senior Product Engineer to join our dynamic team in Cambridge -someone who thrives on solving complex challenges, driving excellence, and making an impact that truly matters.

• Act as technical lead for sustaining activities on current surgical guidance and implantable products. Manage and resolve product issues related to manufacturing, quality, or field performance in collaboration with suppliers.
• Drive improvements to design for manufacturability, serviceability, and cost-efficiency. Work with the Endomag Repair Centre to develop and improve repair processes for existing and new products.
• Support change control processes and documentation in alignment with quality system requirements.
• Support the transfer of new products to manufacturing partners ensuring quality standards are met.
• Collaborate with cross-functional teams including Quality, Regulatory, Operations, and R&D.
• Participate in supplier audits, validations, and technical reviews. Work with supply chain to ensure product is supplied to stringent quality levels.
• Ensure compliance with all applicable medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and MDR.
• Support regulatory submissions through compilation of Design History Files (particularly later stages), device manufacturing records and regulatory documentation.

Due to the nature of the role, UK and international travel will be required - around 25%

As Senior Product Engineer at Endomag, a Hologic company, you will play a critical role in managing the transition of new innovations from R&D to our manufacturing partners, supporting released products and collaborating closely with QA/RA teams and suppliers. You will be responsible for investigating customer feedback, monitoring product performance, and identifying opportunities for improvement in design, manufacturing, and usage. Additionally, you will actively participate in post-market surveillance and work to address emergent failure modes, ensuring that products consistently meet highest quality standards and deliver optimal outcomes for customers and patients.

• A technical or scientific background in engineering.
• Experience in high-tech engineering to exacting standards, ideally within medical device industry.
• Automation experience will be advantageous
• Understanding of quality and regulatory requirements, including ISO 13485, MDSAP, MDD/MDR, and 21 CFR.
• Experience working with international manufacturing or supply partners.
• Excellent problem-solving skills and a detail-oriented approach.
• Excellent written and verbal communication skills.
• Skilled in leading process & continuous improvement projects, ensuring successful implementation within set timelines.
• Comfortable working in a high-compliance, fast-paced environment.
• Experience in Statistical Process Control (SPC) techniques for monitoring and improving manufacturing processes.