Principal Medical Device Manufacturing Engineer
Vor 5 Tagen
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 PositionPTT - Global MSAT & Engineering is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations in a sustainable way. Our focus is integrating SHE, product health, process health with equipment fit for purpose and facility readiness in support of the manufacturing network.
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.
- Lead and support the transfer of medical device and drug-device combination product designs from development to internal/external manufacturing networks, ensuring adherence to product quality and design requirements.
- Conduct Design for Manufacturability/Assembly/Excellence (DFM/DFA/DFx) assessments throughout 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 for equipment qualification, process validation protocols, and Standard Operating Procedures (SOPs), ensuring compliance with regulatory standards.
- Perform evaluations and investigations using root cause analysis tools and methodologies, and apply techniques such as tolerance analysis, failure mode effects analysis, and quality by design to enhance design and process capabilities.
- Recommend assembly, labeling, and packaging techniques for optimal production-performance of devices and combination products.
- Support supplier selection by assessing capabilities to effectively transfer designs to manufacturing.
- Ensure design and manufacturing processes align with product quality and regulatory requirements through comprehensive traceability and validation.
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.
- Educational Background & Experience: B.S./M.S/Ph.D. in science, engineering, or a related field, with extensive experience in medical device or combination product development, industrialization, sustaining engineering, and manufacturing.
- Manufacturing Expertise: Proficient in manufacturing processes, mechanical device assembly, combination product finishing and packaging and ideally plastic injection molding.
- Technical Skills: Expertise in statistical data analysis and interpretation, technical report writing and reviewing. Proven knowledge with risk management tools and ability to develop/Failure Mode and Effects Analysis (FMEAs), and assess non-compliance evaluations.
- Regulatory Knowledge: Strong understanding of Design Controls for regulatory compliance, including ISO 13485, GDP/GLP/GMP, Design History Files, URS, FAT/SAT, test protocols, technical reports, and control systems.
- Process Development Leadership: Proven experience in leading/supporting process development from feasibility to New Product Introduction.
- Collaboration & Communication: Demonstrated ability to work effectively in a matrix organization with cross-functional teams, along with excellent oral and written communication skills.
- Organization & Detail Orientation: Highly organized and detail-oriented, with a track record of managing complex projects successfully.
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.
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.
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.
Roche is an Equal Opportunity Employer.
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