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Principal Device Engineer at Roche - ApplyBlast

Principal Device Engineer

Roche

3 months ago

4.1 on Glassdoor

Basel, Switzerland

Onsite

Full Time

Senior

0 applicants

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About this role

This role serves as a Technical Project Lead or Subject Matter Expert within Roche's Device Development department, focusing on the engineering and lifecycle management of drug delivery devices. The position involves applying deep mechanical engineering expertise to solve complex challenges for combination products, ensuring compliance with global regulatory standards like ISO 13485 and 21 CFR Part 820. Key duties include leading internal and external technical investigations, authoring comprehensive design control documentation, and collaborating with cross-functional teams to advance products from early development to commercialization.

Responsibilities

Lead robust development of combination products and medical devices
Apply design controls to ensure device performance throughout the lifecycle
Collaborate with external partners on mechanical designs for combination products
Lead technical investigations to resolve complex design-related issues
Author and manage comprehensive design control documentation

Skills

Qualifications

BSc or MSc in EngineeringISO 13485 Knowledge21 CFR Part 820 ExpertisecGxP ExperienceQSR Knowledge

About Roche

roche.com

Headquarters

Basel, Basel-Stadt, Switzerland

Company Size

10001+ employees

Founded

1896

View Profile

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.