Principal Device Engineer with Pen- / Autoinjector expertise — Roche
NewCHF 68'000 - 103'000
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 68'000 - 103'000
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.
- Additionally, you will take on strategic responsibilities and contribute to efforts led by the Device Engineering leadership team.
- This role reports to the Section Head of Device Engineering and is integrated into the Roche Device Development function.
Main responsibilities
- Additionally, you will take on strategic responsibilities and contribute to efforts led by the Device Engineering leadership team.
- This role reports to the Section Head of Device Engineering and is integrated into the Roche Device Development function.
- Act as project leader / team leader / technical expert to successfully bring combination products and medical devices to the market
- Evaluation of new and breakthrough technologies.
Application process
- Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product
- Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation.
- Forecast and plan resource demands for device development projects.
- Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices
- knowledge of the regulatory landscape to ensure standard compliant designs (e.g.
- ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30) Who you are:
- You have university level education (engineering degree or related discipline).
- You have a minimum 10-year proven track record in mechanical engineering and drug delivery device development with experience in pharma or other closely-regulated environments, under current Good Practice (cGxP), Quality System Regulation (QSR), or similar working practices.
Additional details
- Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g.
