Sr. Engineer II, Process Development

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.Join us and help shape wherever we go next!Advancing healthcare with heartJob SummaryThe Senior Engineer II, Process Development (NPI) is an intermediate expert level role who independently leads significant technical projects and serves as a key contributor to major process development initiatives within New Product Introduction (NPI). This role involves applying advanced knowledge of Manufacturing Process Strategies, DFM/DFA, Lean, and Six Sigma to design, develop, integrate, and validate robust manufacturing processes into the Value Streams.The Senior Engineer II provides technical leadership within NPI project teams, mentors junior engineers, and plays a vital role in ensuring technical quality and successful implementation for new product launches.Job Details/ResponsibilitiesTechnical Leadership:Independently for mid-scale projects designs, develops, integrates, and validates new or modified manufacturing processes to support New Product Introduction (NPI) in compliance with TMC Quality System requirements and regulatory standards.Applies extensive technical knowledge and experience to lead complex process developments design and validation efforts. Possesses deep expertise in Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.Participate R&D and Design Engineering teams during early product development in the identification, evaluation, and implementation of new process technologies and equipment to improve OEE and reduce manufacturing cost. Leads the identification and documentation of critical process parameters (CPPs), material specifications, and equipment needs for NPI projects.Solve complex technical challenges encountered during NPI and scale-up. Provides technical leadership and mentorship to junior engineers and project teams within NPI projects.Process Development and InnovationEnforce Manufacturing Process Design standards. Apply Design For Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.Contributes to the development of new process technologies for NPI projects, considering factors like OEE and manufacturing cost.Lead execution of proof-of-concept for manufacturing methods for NPI. Lead the execution of laboratory-polit scale processes and prototypes into scalable manufacturing processes by identifying critical process parameters (CPPs), material specifications, and equipment needs at platform level.Develop and lead process risk analysis (EFMEA, pFMEA) and execute process development activities including, commissioning (URS/FRS/Traceability Matrix), characterization and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards.Lead the technical execution acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation.May contribute to the assessment of Patent Situation Statements and intellectual property strategy related to manufacturing processes for new products.Apply knowledge of industry's common business transaction systems (e.g., SAP, MES, Change Control, Ariba)Lead improvements activities using Lean and Six Sigma methodologies applied to NPI processes.Project Planning and Execution:Manages all technical aspects of assigned projects, including planning, execution, and reporting, often overseeing the work of less experienced engineers.Contributes significantly to project scope definition, budgeting, scheduling, and risk assessment.Job Responsibilities (continued)Design Transfer & Scale-UpLead scale-up of laboratory or pilot processes to industrial production settings—including specification of equipment, methods, automation, throughput planning, and cost targets for assigned NPI projects.Lead executions of design transfer frameworks for assigned projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology transfer documentation.Contributes to the development and refinement of design transfer processes for NPI projects.Cross-Functional Collaboration:Collaborates effectively with cross-functional teams including Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing.Attend project meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication.Communicates complex technical information effectively, resolve technical issues, and ensure successful project delivery.Perform other job-related duties when assigned.Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.Working Conditions/Physical RequirementsTechnical Leadership:Demonstrated experience in developing, scaling, and validating manufacturing processes for medical devices or other regulated industries.Advanced understanding of materials, equipment selection, and process technologies such as molding, joining, assembly, laser processing, or other advanced manufacturing methods used in medical device production.Advanced understanding of Design for Manufacturability (DFM), process characterization, DOE, and statistical analysis.Familiarity with automation, Industry 4.0 concepts, and equipment integration a strong plus.Strong knowledge of FDA regulations, ISO 13485, GMP, and risk management practices (e.g., FMEA, pFMEA).Demonstrated experience in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred.Communication Skills:Strong ability to communicate technical information clearly and effectively to project teams, management, and stakeholders. Proficient in preparing technical documentation and presentations.Problem-Solving Skills:Advanced level understanding of root cause analysis, troubleshooting, and resolution of complex manufacturing and product development issues.Proficient in tools such as Minitab, JMP, and MS Office Suite; working knowledge of CAD and PLM systems is a plus.Effective use of MS Office Suite Knowledge, Skills and Abilities (KSA)Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Master’s degree desirable.10+ years in process development, manufacturing engineering, or product development, with at least 6 years in the medical device or other highly regulated industry.Lean Six Sigma It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.