Terumo BCT Disposable Development Engineer 3 in Lakewood, Colorado

Disposable Development Engineer 3Date: Aug 8, 2018Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 15763JOB SUMMARYWork requires originality and judgment in the independent evaluation,selection, and substantial adaptation and modification of standardtechniques, procedures, and criteria. Performs work which requires abroad knowledge of precedents in the specialty area and a good knowledge ofprinciples and practices of related specialties. Duties are assigned toprovide experience and familiarization with engineering methods, independentthinking, and company practices and policies.ESSENTIAL DUTIESParticipates in or manages development of project scope and estimates,initiation of requests for capital when required, management of costs tobudget, specification and traceability of design requirements and userneeds, support of verification and validation activities, risk managementincluding FMEA/pFMEA, and final documentation in accordance withacceptable engineering practices and design controls.Perform independent evaluation, selection, and application in makingadaptations and modifications to projects.Receives assigned total project leadership responsibilities on a portion ofmajor significant projects and will be given total management responsibilityfor smaller projects.Manages and provides leadership for the functional group's development,direction, and effectiveness, adhering to organizational policies andprocesses and supporting overall business and corporate objectives.Implements and has a strong understanding of FDA and other regulatoryrequirements.Initiates and manages design and process changes.Applies technology principles to multiple tasks. Working knowledge ofcross-functional and related technical areas.Highlights risks and understands how to approach and complete tasks,avoiding serious delays and considerable expenditure of time and resources.Advises team members pro-actively on technical ideas and promotes skilldevelopment of team work.Interacts with peers across projects to secure resources and commitments.Handles frequent inter-organizational and outside customer contacts.Represents the organization in providing solutions to difficult technicalissues associated with specific projects.Follows technical specification requirements and provides feedback on varioustechnical processes and procedures.Presents effectively complex technical information/analysis, and respondsto questions from technical staff members and management.Works cooperatively and effectively within a team environment to achievecommon goals and results, often influencing the outcome of the team(s).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.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, preferred.ExperienceMinimum 4 years experience.Design experience with FDA regulated design controls for Class II/IIImedical devices, strongly preferred.SkillsRequires demonstrated skills in technical innovation, technicalleadership, mechanical and or chemical engineering, fluids engineering,and cellular biology.Strong interactive skills in general communication, cross-functionalparticipation and influence, mentoring and acceptance of guidance,technical leadership, project management, coordination withcross-functional team member, team behavior, and support forsubordinates, junior engineers, technicians, and management.Strong technical problem solving skills.Mechanical and electronic ability aptitude to assist with equipmenttrouble-shooting.Understanding of and adherence to GMP practices and FDA regulations.Understanding of Design for Manufacturing (DFM) and Design for Assembly(DFA) principles.Knowled