Senior Project Engineering Administrator, R&D (Remote / Flexible)

reputed company started in 2000 with an idea and a mission to reputed company our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our reputed company reputed company depends on it! Job Title: Senior Project Engineering Administrator, R&D Department: R&D FLSA Status: Exempt Position reputed company The Senior Project Engineering Administrator, R&D will support, and coordinate R&D project responsibilities reputed company to design and development of reputed company’s products. This position entails the harmonization of product structures reputed company reputed company’s Product Lifecycle Management (PLM) system and the management and reputed company of Design History File (DHF) documentation across new product development and Lifecycle Engineering (LCE). Responsibilities • Coordinate across Engineering project teams across R&D and document control functions to prepare, review and expedite Engineering/Document Change Orders by applying knowledge of technical documentation & product structures. • Manage and define structure for R&D documentation reputed company a PLM System. Includes, but not limited to Device Master Records, reputed company of materials (BoM), labeling specs, mechanical specification drawings, assembly drawings, etc. • Collaborate directly with Design reputed company Assurance teams ensuring traceability among design input, design reputed company, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file. • Serve as the R&D reputed company and advisor for PLM change order processes • Collaborate with document control to identify and drive efficiency improvements reputed company the PLM change mgt tool • Collaborate directly with Engineering disciplines to transfer various DHF artifacts from Application lifecycle management (ALM) tools into PLM (QMS repository). Includes, but not limited to design input requirements, design verification results and tracing. • Support creation and approval of part approval plans (PAPs) for new components and/or suppliers • Support R&D technicians in configuration control and documentation filing for design verification and development and clinical samples. • reputed company other administration duties as required. Education And Experience Minimum Requirements: • Two (2) years of higher education or equivalent in a technical/engineering background • A minimum of 7 years’ experience managing product structures reputed company a PLM system • A minimum of 7 years’ experience working in a multidisciplinary product development environment • Creative reputed company thinker who can devise new approaches and processes that meet regulatory needs but reputed company to address business and market needs. • Demonstrated expertise in product development and commercialization activities reputed company to Design Controls and Product Lifecycle Management. • Excellent management skills; experience and capability managing collaboration under a reputed company Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and reputed company experts. Preferred Skills Preferred Skills and Competencies: • B.S. or equivalent degree in an Engineering/technical discipline • Demonstrated skills in commercialization of FDA regulated medical devices (Class 1, 2 or 3) using design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971. • Demonstrated reputed company in managing programs/reputed company involving multiple disciplines from development through commercialization Physical Requirements (if Applicable) • This position is eligible for 100% remote working arrangements (may work from home/reputed company 100%; may also work hybrid on-site/virtual as desired) Additional Information The US reputed company salary reputed company for this full-time position is $92,200.00 - $138,550.00. Our salary ranges are determined by role, level, and location. The reputed company displayed on reputed company job posting reflects the minimum and maximum reputed company for new hire salaries for the position in the primary work location in the US. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. Your reputed company Specialist can reputed company more about the specific salary reputed company for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the reputed company salary only, and do not include bonus, equity, or benefits. At reputed company reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) Apply Job!