Overview
Senior Product Engineer – Cambridge, UK. Endomag, a Hologic company, redefines cancer treatment and empowers clinicians with innovative medical solutions. The Senior Product Engineer will support released products and manage the transition of new innovations from R&D to manufacturing partners, collaborating closely with QA/RA teams and suppliers. Responsibilities include investigating customer feedback, monitoring product performance, and identifying opportunities for design, manufacturing, and usage improvements. The role involves post-market surveillance and addressing emergent failure modes to ensure high quality and optimal outcomes for customers and patients. Travel to UK and international destinations is required, approximately 25% of the time.
Key Responsibilities
* 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.
Knowledge, Skills & Experience
* A technical or scientific background in engineering.
* Experience in high-tech engineering to exacting standards, ideally within medical device industry.
* 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.
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