Terumo BCT Product Lifecycle Engineer, Disposables in Lakewood, Colorado

Product Lifecycle Engineer, DisposablesDate: May 14, 2018Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 15881JOB TITLE: Product Lifecycle Engineer, DisposablesJOB SUMMARYProvide cross functional, influential leadership and product subject matterexpertise to the company over the life cycle of the product(s) assigned.ESSENTIAL DUTIESActs as the subject matter expert on assigned Disposables product line(s)over the the life cycle of the product.Reviews and approves product documentation that may include design reviews,verifications, lower level requirements, and product specifications, asapplicable.Consult and advise on product changes through design control processes andchange control processes including: design change implementation,production quality issues, field quality issues, production processchanges, regulatory filings/registrations, supplier quality changes.Advise on content for systems product documentation including: ProductRequirements, System Architecture, User and Environmental Analysis, andRisk ManagementMay contribute guidance for standards for product testing and testingprocedures; ensures consistency across product lines where applicable bypartnering with other SMEs.Reviews and updates Technical File for assigned product(s), andunderstands applicability of required standards.Could perform product training for other associatesMay utilize hands on time with the products and platform to maintain productknowledge or train other associatesWorking knowledge of cross-functional and related technical areas (such asQuality, Manufacturing and Regulatory).Advises team members pro-actively on technical ideas and product knowledge andpromotes development of team work and product knowledge.Participates in inter-organizational and outside customer contacts as needed.Represents the organization in providing solutions to difficult technicalissues associated with specific product(s) and projects.Works cooperatively and effectively within a team environment to achievecommon goals and results, often influencing the outcome of the team(s).Presents complex technical information and analysis, and respondseffectively to questions from technical staff members and management, asneededDisplays accessibility and sought out for consultation on a broad range ofcomplex technical and industry issues by engineering staff and management.OTHER DUTIES AND RESPONSIBILITIESWork direction responsibility may include technicians and junior engineers.May work with manufacturing and other functional groups on manufacturing andregulatory compliance issues.Must consult or collaborate with Product Lifecycle Engineers for interfacingequipment.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor's degree or equivalent of education and experience sufficient tosuccessfully perform the essential functions of the job may be considered.Bachelor of Science Degree in Engineering is preferred.ExperienceMinimum 4 years experience.Two years of GMP manufacturing experience required.SkillsDemonstrated interactive skills in, cross functional participation andinfluence, mentoring and acceptance of guidance, technical leadership,project management, coordination with cross functional team member, teambehavior, and support for subordinates, junior engineers, technicians,and manaExperience in medical device, pharmaceutical, or other regulated industry.Represents the organization as the prime technical contact on products.Interacts with senior level external personnel on significant technicalmatters often requiring coordination between organizations.Follows and consults in the development of technical specificationrequirements and provides significant input on technical procedures on variousprocesses that impact multiple disciplines.Exhibits strong managerial courage both technically and personallyRequires demonstrated skills in technical innovation, technicalleadership, mechanical or chemical engineering, fluids engineering, andcellular biology.Exhibit