Product Development Engineer

Hologic, Inc.; Cambridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading healthcare company in Cambridge seeks a Product Development Engineer to design and develop innovative solutions for cancer care. This role involves owning mechanical design, managing projects, and ensuring compliance with regulatory standards. The ideal candidate has a background in Mechanical Design or Materials Engineering, strong CAD skills, and project management experience. Join a dynamic team focused on making impactful advancements in medical technology.

Qualifications

• Educational background in Mechanical Design, Materials Engineering, or equivalent experience.
• Experience in mechanical product development within regulated industries.
• Knowledge of ISO standards (13485, 14971).

Responsibilities

• Own mechanical design of product and sub-assemblies from concept to validation.
• Project manage work streams, including plans, risks, and budgets.
• Ensure robust risk management and compliance with relevant standards.

Skills

CAD knowledge (e.g. SolidWorks)

Mechanical Design

Problem-solving skills

Project management

Collaboration

Education

Degree in Mechanical Design or Materials Engineering

Tools

SolidWorks

Job description

Overview

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 looking for a talented Product Development 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 Development Engineer at Endomag, a Hologic company, you will play a critical role in our development programs with a focus on hands-on mechanical design and development of components, instruments, sub-assemblies and disposable devices within our Breast Surgery product portfolio. You will define requirements, design and prototype solutions, and lead verification/validation activities within a regulated environment (ISO 13485). You will collaborate closely with a network of third-party suppliers, contract development organisations, consultants and internal cross functional teams to deliver innovative, compliant and manufacturable products.

Responsibilities

• Own mechanical design of product and sub-assemblies from concept through detailed design, prototyping and verification/validation, ensuring safety, performance and manufacturability
• Perform mechanical architecture, materials selection, tolerance analysis (GD&T). Design for manufacture, assembly and serviceability; generate CAD models and drawings
• Project manage work streams: build and track plans, risks and budgets, drive decisions, report status, ensure delivery to ISO 13485 design controls
• Lead relationships with external partners (suppliers, consultants, contract manufacturers)
• Ensure robust risk management (ISO 14971) and compliance with relevant standards
• Collaborate closely with cross-functional teams including Product Engineering, Quality, Marketing, Regulatory Affairs, and our Implantables Team
• Prepare and maintain detailed documentation for all design and development activities including design specifications, test protocols and compliance reports

Knowledge, Skills & Experience

• Educational background in Mechanical Design, Materials Engineering, (or a related field) or equivalent experience in mechanical product development within regulated industries
• Knowledge of CAD (e.g. SolidWorks), GD&T, materials and plastics selection, tolerance stack-ups, DFM/DFA
• Project management skills—able to plan, prioritise, and keep teams on track and experience leading external suppliers/contractors
• Experience with design verification and validation, and working through product development phases
• Working knowledge of ISO 13485, ISO 14971, ISO 10993, IEC 62366
• Excellent problem-solving and communication skills and a collaborative team spirit
• Eager to learn, with a drive for continuous improvement

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!