Job Description
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!
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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