Senior Product Engineer

Hologic; Cambridgeshire and Peterborough; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading medical technology company is seeking a Senior Product Engineer in Cambridge, UK. This role involves supporting product innovations, enhancing quality, and ensuring compliance with medical regulations. Candidates should have a strong background in engineering and experience in the medical device industry, along with excellent problem-solving and communication skills.

Qualifications

• Experience in high-tech engineering, preferably in the medical device industry.
• Understanding of quality and regulatory requirements, including ISO 13485.
• Experience with international manufacturing or supply partners.

Responsibilities

• Act as a technical lead for sustaining activities on current products.
• Drive improvements to design for manufacturability and cost-efficiency.
• Support regulatory submissions and ensure compliance with medical device regulations.

Skills

Problem-solving skills

Detail-oriented

Excellent communication skills

Leading process improvement projects

Statistical Process Control (SPC)

Education

Technical or scientific background in engineering

Job description

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.