Product Engineer

Cambridge, Cambridgeshire, United Kingdom

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 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.

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

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

KEY RESPONSIBILITIES

• Support the transfer of new products from R&D to manufacturing partners ensuring quality standards are met.
• Investigate emerging trending issues with products and work with manufacturers to resolve and address.
• Support change control processes and documentation in alignment with quality system requirements.
• Collaborate with cross‑functional teams including Quality, Regulatory, Operations, and R&D.
• Work with the Repair Centre team to develop and improve repair processes for existing and new products.
• 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.

KNOWLEDGE, SKILLS & EXPERIENCE

• A technical or scientific background in engineering.
• Experience in high‑tech engineering to exacting standards, ideally within the medical device industry.
• Understanding of quality and regulatory requirements, including ISO 13485, MDSAP, MDD/MDR, and 21 CFR.
• Excellent problem‑solving skills and a detail‑oriented approach. Problem‑solving methodology (8D, 5 Whys)
• Excellent written and verbal communication skills.
• Comfortable working in a high‑compliance, fast‑paced environment.
• Experience in Statistical Process Control (SPC) techniques for monitoring and improving manufacturing processes.

Ready to Make an Impact?

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

Innovate with Purpose: Work at the forefront of life‑changing medical technology.

Collaborative Culture: Join a friendly, supportive team where your contributions matter.

Personal Growth: Expand your skills in a fast‑growing, global company.

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