Senior Staff Process Engineer (MSAT)

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. Join Roche, where every voice matters.

The Position

Are you passionate about leading innovative engineering projects and elevating product quality and robustness? We are seeking a Senior Staff Process Engineer to join our dynamic team, where you will spearhead critical process engineering investigations, identify failure modes, and implement cutting-edge methods to enhance our ePlex products.

In this role, you will drive process development, characterization, and improvement activities for both new and existing product lines. Your expertise will be vital in designing and implementing new automation equipment, assessing production for quality enhancements, and validating new or improved processes and manufacturing equipment. You will work with advanced processes including surface treatment, precision dispensing of fluids and adhesives, and other sophisticated material sciences technologies such as plasma treatment, CO2 cleaning processes, and laser bonding.

Your strong communication skills will enable you to interact effectively with key decision-makers across various departments, including quality assurance, research and development, and manufacturing. Join us as we bridge the lines of communication, foster innovation, and elevate our products to new heights.

The Opportunity

• Continuously improve production processes in manufacturing

• Lead project teams as part of product improvements, automation, and quality improvements

• Troubleshoot issues that arise within the manufacturing process

• Lead or participate in teams to identify critical product or process attributes and parameters, design studies to characterize parameters (DOE), and evaluate risks and mitigations (pFMEAs/dFMEAs) 

• Apply standard project management tools and principles to ensure project success

• Serve as advocate and role model for integrating change into the organization as well as serve as departmental role model of professional behavior and presence.

• Lead change control activities within cross functional departments

• Create and approve Product BOM’s, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions.

• Follow cGMP and ISO standards

Who you are

• Bachelors in Engineering, 15+ years related experience or MS degree in Engineering and 10+ years related experience depending on level, background and industry.

• Experience in designing/implementing manufacturing processes, equipment and fixtures.

• Project Management successes with expertise influencing key decision makers within a matrix environment.

• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential.

• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.

• Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.

• Proficient using SolidWorks preferred.

• Experience with design transfer activities for medical devices is a plus.

• Experience designing/implementing automation equipment is a plus.

• Chemical – Familiarity with multi-step organic chemical purification is a plus.

• Material Science knowledge is a plus.

• Experience with surface treatment (i.e. plasma, CO2 cleaning), laser bonding and dispensing is a plus.

Skills – Technical

• Must be able to lead cross-functional teams in problem solving, development of improvement plans and root cause-analysis.

• Demonstrated ability to support product launches and provide technical support in troubleshooting and resolving tooling/equipment issues.

• Experience in DFM analysis for various manufacturing processes, e.g. critical to quality attribu