Device Industrialisation Engineer Full Time

Device Industrialisation Engineer

Join a dynamic team dedicated to advancing medical device innovation at the forefront of healthcare. As a Device Industrialisation Engineer, you will play a pivotal role within the Industrialisation Team at the Device Development Centre, contributing to cutting-edge projects in complex generics and biosimilar workstreams. This is an exciting opportunity to influence the scale-up, manufacturing, and transfer of life-changing medical devices and combination products, ensuring they meet stringent industry standards and regulations.

What You’ll Bring

• Proven experience (5+ years) in medical device and/or combination product development within the pharmaceutical, medical devices, or related industry.
• Strong expertise in tech/design transfer activities moving from R&D into production.
• Proficiency in writing and reviewing manufacturing-related documentation, including DHF sections.
• Solid understanding of supplier management, capital equipment procurement, and process development tools.
• Knowledge of risk management and validation methods aligned with industry standards such as ISO13485, ISO14971, cGMP, and CFR210/211.
• Hands-on experience in device scale-up activities, including DFM, DFA, precision component moulding, and assembly.
• Ability to operate within a matrix management structure and interface effectively with external CMOs and suppliers.
• Fluency in English and a relevant degree in mechanical, chemical, process engineering, pharmaceutical sciences, or a related field.

Nice To Have

• Expertise in secondary & tertiary packaging development and manufacturing.
• Experience with shipping & transport testing for medical products.
• Additional certifications or training related to industry standards and risk management.
• Exposure to sterile injectables, fill-finish processes, and assembly.

Preferred Education & Experience

• Master’s degree, PhD, or university degree in a relevant scientific or engineering discipline.
• Demonstrable track record managing complex projects involving tech transfer and scale-up of MedTech products.
• Proven ability to lead collaboration with CMOs and equipment suppliers to deliver results.

Other Requirements

• At least 50% of work in the Cambridge office post-induction; some travel may be necessary.
• Availability to start ASAP; contract duration approximately 12 months.

Ready to make an impact in medical technology innovation? Apply now and bring your expertise to a team committed to improving lives worldwide!
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.