Join Us as a Senior Product Engineer!
Location: Cambridge, UK
Are you ready to embark on a career that truly makes a difference? At Endomag, a Hologic company, we’re on a mission to transform cancer care through innovative medical solutions. We’re looking for a Senior Product Engineer to join our vibrant team in Cambridge. If you thrive on solving complex challenges and want to make a meaningful impact, this is the opportunity for you!
Your Role
As a Senior Product Engineer, you will be at the heart of our operations, supporting released products and facilitating the transition of new innovations from R&D to our manufacturing partners. You’ll collaborate closely with QA/RA teams and suppliers to:
* Investigate customer feedback and monitor product performance.
* Identify opportunities for improvement in design, manufacturing, and usage.
* Participate in post-market surveillance and address emergent failure modes.
Travel is part of the adventure! Expect to be on the road about 25% of the time, both in the UK and internationally.
Key Responsibilities
* Lead technical efforts for sustaining activities on current surgical guidance and implantable products.
* Drive improvements in design for manufacturability, serviceability, and cost-efficiency.
* Support change control processes and documentation in line with quality system requirements.
* Ensure quality standards are met during the transfer of new products to manufacturing partners.
* Collaborate with cross-functional teams, including Quality, Regulatory, Operations, and R&D.
* Participate in supplier audits, validations, and technical reviews.
* Ensure compliance with medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.
* Support regulatory submissions through the compilation of Design History Files and other documentation.
What You Bring
* A technical or scientific background in engineering.
* Experience in high-tech engineering, preferably in the medical device industry.
* Understanding of quality and regulatory requirements, including ISO 13485 and MDR.
* Experience working with international manufacturing or supply partners.
* Excellent problem-solving skills and a detail-oriented approach.
* Strong written and verbal communication skills.
* Proven ability to lead process and continuous improvement projects.
* Comfortable in a high-compliance, fast-paced environment.
* Experience with Statistical Process Control (SPC) techniques.
Why Join Us?
Innovate with Purpose: Work at the forefront of life-changing medical technology.
Collaborative Culture: Join a friendly, supportive team where your contributions truly matter.
Personal Growth: Expand your skills in a fast-growing, global company.
Ready to make an impact? If you have the right skills and experience, we’d love to hear from you. Apply today and take the next step in your career!