Medical Device Manufacturing Engineer

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

The Opportunity:

Are you ready to take on a pivotal role as a Medical Device Manufacturing Engineer at Roche? As 60% of our future product portfolio will feature Device presentations, this is an exceptional opportunity to contribute to the design and implementation of manufacturing processes, instrumentation, and equipment. Your focus on quality, cost-efficiency, and time to market will be crucial in ensuring the success of our products. Join our team and make a significant impact on the production and supply chain readiness of our devices.

• Support and lead design transfer activities of medical device and drug-device combination product designs from development into the internal/external manufacturing network.

• Conduct Design for Manufacturability/Assembly/Excellence (DFM/DFA/DFx) assessments during development, industrialization, and sustaining engineering projects.

• Utilize state-of-the-art technology to lead process development for clinical and commercial production across our manufacturing network.

• Characterize and evaluate critical process parameters (CPPs) using tools such as Design of Experiments (DOEs) to fully understand the impact of processes variances to product requirements and its performance.

• Author and review documentation related to equipment qualification activities, process validation protocols, and Standard Operating Procedures (SOPs).

• Support or lead evaluations and investigations using root cause analysis tools and methodologies.

• Apply tools to assess design and process capabilities, such as tolerance analysis, failure mode effects analysis, and quality by design.

• Ensure product quality and design requirements are traced throughout the product development process.

• Recommend assembly, labeling, and packaging processes and techniques for optimal performance of devices and combination products.

• Support supplier selection by assessing their capabilities in transferring designs to manufacturing.

Who You Are:

We are seeking a highly skilled and experienced individual to join our team as a Medical Device Manufacturing Engineer. Your in-depth specialist knowledge and expertise in devices and combination products, engineering, design, and process will be invaluable in this role.

• Extensive work experience in medical device or combination product development, industrialization, sustaining engineering, and manufacturing.

• B.S./M.S/Ph.D. degree in science, engineering, or a related field.

• Experience in manufacturing processes, with an emphasis on plastic injection molding, mechanical device assembly, and combination product finishing and packaging.

• Expertise in statistical handling and interpretation of data, technical report writing and reviewing.

• Experience in leading/supporting process development from feasibility to New Product Introduction.

• Familiarity with risk management tools and ability to develop Failure Mode and Effects Analysis (FMEAs) and assess changes and non-compliances.

• Knowledge of Design Controls for regulatory compliance, including ISO 13485, GDP/GLP/GMP, Design History Files, User Requirement Specifications (URS), Factory/Site Acceptance Testing (FAT/SAT), test protocols, technical reports, and control systems.

• Proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment.

• Excellent oral and written communication skills.

• Ability to work with external design/development and production partners.

• Highly organized and detail-oriented.

If you are ready to take on this challenging role and contribute to the success of Roche's Medical Device manufacturing efforts, apply now! We look forward to reviewing your application.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.