Principal Device Engineer With Pen- / Autoinjector Expertise
Roche UK
Pen injector development expertise
Auto injector development experience
Design control documentation creation
This role involves acting as a project leader to successfully bring combination products and medical devices to the market while evaluating new breakthrough technologies
Job Summary
This role involves acting as a project leader to successfully bring combination products and medical devices to the market while evaluating new breakthrough technologies.
The position requires extensive cross-functional collaboration with Quality Assurance, Regulatory Affairs, Clinical, and Commercial teams to ensure standard compliant designs.
Roche fosters a culture of personal expression and open dialogue where every voice matters to prevent, stop, and cure diseases globally.
Matching Summary
This role involves acting as a project leader to successfully bring combination products and medical devices to the market while evaluating new breakthrough technologies.
Skills & Requirements
Must-have
Pen injector development expertise
Auto injector development experience
Design control documentation creation
ISO 13485 and ISO 14971 knowledge
21 CFR 820 regulatory compliance
Risk assessment and tolerance analysis
Nice-to-have
Strategic thinking capabilities
Excellent interpersonal communication skills
Proficiency in German language
Experience with Health Authority interactions
Statistical techniques application
Key Requirements
Minimum 10 years mechanical engineering experience