Principal Device Engineer — Roche
NewCHF 85'500 - 129'500
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 3 days ago
SalaryCHF 85'500 - 129'500
Role overview
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
- At Roche you can show up as yourself, embraced for the unique qualities you bring.
- Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
Application process
- Serve as the Technical Project Lead or Subject Matter Expert to drive the robust development of combination products and medical devices, ensuring a seamless advancement into clinical phases and commercial market applications.
- deep engineering expertise and strategic insights, establish robust technical product requirements and develop drug-device combination product design solutions to assure devices maintain the required level of performance throughout the entire product lifecycle.
- Collaborate with external partners providing technical oversight on mechanical designs for combination products while ensuring high performance, design robustness and fostering innovation.
- Lead internal and external technical investigations to swiftly resolve complex, design-related issues using structured problem-solving methodologies.
- Author and manage comprehensive design control documentation - including Design Development Plans, User Requirements Specifications (URS), Design Inputs/Outputs, Verification/Validation Plans, conformity assessments, and risk management files.
- Navigate the global regulatory landscape to ensure all product designs and processes comply with industry standards, specifically ISO 13485, ISO 14971, and 21 CFR Part 820 (with an emphasis on 820.30 Design Controls). Who you are:
- University degree (BSc or MSc) in engineering or a related technical discipline from an accredited institution.
- 10+ years of experience in mechanical engineering and drug delivery device development within pharma or highly regulated environments (cGxP, QSR).
Company and context
- The Position Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients.
- Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs.
- The mandate is to expertly deliver the pipeline and supply quality products to patients.
- The Device Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio.
- Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.
- Device Engineering combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.
- The opportunity: This hands-on role drives engineering excellence by applying design controls, solving complex device engineering challenges, and providing strategic technical guidance to ensure robust product development and compliance.
- In this role, you will engage in cross-functional collaboration, particularly with Quality Assurance, Device MSAT, Regulatory Affairs, Pharmaceutical Development, Clinical, and Commercial teams.
Additional details
- Apply deep engineering expertise and strategic insights, establish robust technical product requirements and develop drug-device combination product design solutions to assure devices maintain the required level of performance throughout the entire product lifecycle.
- Navigate the global regulatory landscape to ensure all product designs and processes comply with industry standards, specifically ISO 13485, ISO 14971, and 21 CFR Part 820 (with an emphasis on 820.30 Design Controls).
Notes and original content
- Who you are:
