The Position The Senior Process Engineer is responsible for designing & implementing new manufacturing processes as well as the improvement and support of existing processes used in the formulation and filling of diagnostic assays of high medical value and the assembly and kitting of laboratory consumables. This engineer is responsible for partnering with the Validations, Maintenance and Operations team to ensure our manufacturing processes are robust and have the capability and capacity to meet the needs of the business. As a senior engineer, you will be expected to work with minimal oversight and apply lean manufacturing principles to identify and implement process improvements that will support our patients and customers. Responsibilities: Responsible for the quality and performance of an assigned production area; the engineer will drive process capability, quality, cost improvements and implement solutions to improve yield and throughput in a high mix high volume environment. Apply program/project management tools to define, monitor, and communicate project timelines, ensure timely achievement of overall project goals, and establish priorities that are in line with the overall business needs. Ability to quickly troubleshoot process opportunities and provide technical support to ensure production equipment maintains maximum machine uptime. Responsible for writing URS, FS, DS, and SOWs for new projects impacting the production process area assigned. Apply DMAIC principles to solve manufacturing process issues including conducting process characterizations and application of SPC where it is beneficial. Responsible for area RCAs and solutions implemented for NCRs, CAPAs and Audit closure on manufacturing process related issues in your assigned production area. Utilizes Continuous improvement/Lean/Six Sigma manufacturing concepts to improve processes. Provides daily frontline manufacturing technical support in partnership with the maintenance organization Assist in designing and implementing new equipment and tools to improve manufacturing efficiencies, reduce ergonomic stress, and improve quality. Partner with operations to ensure compliance to cGMP, FDA and ISO13485 guidelines. Establish and maintain process maps, value stream maps, manufacturing work instructions and pFMEAs in your assigned area. Provide technical guidance to shop floor associates and process engineers as well as serve as a mentor to other engineers. Collaborate with other functions in MTS (manufacturing technical support) such as validations, maintenance and product transfer to ensure alignment of MTS projects are communicated effectively and implemented in a structured and thorough way. MINIMUM QUALIFICATIONS: Formal Training/Education: Bachelor’s degree in Engineering/Engineering Technology or Life Science discipline required Experience: Minimum of 4 years related experience in a manufacturing environment Knowledge, Skills and Abilities: Ability to partner with multiple functions to achieve results is required Strong knowledge of process engineering principles and the application of lean manufacturing principles is required Experience using AutoCAD, ProE or other modeling software is preferred Experience in reagent or instrument manufacturing for a Medical Device or Pharmaceutical company is preferred Experience within a GxP environment and superior GxP documentation experience is preferred Relocation is available for this role. 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. Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.