Job Description
We are looking for a highly skilled medical device engineer to join the Device Development Centre. This role is a key part of the Industrialisation team, contributing to the successful development and scale-up of medical devices and combination products within complex generics and biosimilars programs.
Key Responsibilities
- Lead and deliver industrialization activities across medical device and combination product projects
- Support technology/design transfer from R&D into manufacturing environments
- Contribute to and author manufacturing sections of Design History File (DHF) documentation
- Drive process development, validation, and risk management using industry-standard methodologies
- Provide technical expertise in device scale-up activities, including:
- Design for Manufacturing (DFM)
- Design for Assembly (DFA)
- Precision component moulding and assembly
- Collaborate effectively within a matrix organization and cross-functional teams
- Manage supplier interactions, including CMOs and capital equipment vendors
- Support capital equipment acquisition and implementation
Experience & Skills
- 5+ years of experience in medical devices and/or combination products
- Proven experience working in cross-functional and matrix teams
- Strong background in technology transfer and product scale-up
- Hands‑on experience with CMOs and capital equipment suppliers
- Demonstrated ability to solve complex problems and make pragmatic decisions
- Experience in risk management and validation processes
Required Qualifications
- Master’s / PhD
- Mechanical Engineering / Chemical / Process Engineering
- Pharmaceutical Sciences / Life Sciences or related field
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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