Sr. Program Manager R&D

Company: System One
Location: Brookline
Posted on: June 17, 2022

Job Description:

Sr. Program Manager R&D Degree: - BS degree in related Engineering or Scientific discipline Experience: - 12+ years of experience in product development managing projects from Concept to Commercialization phase - 7-10 yrs. exp. in med device and project management - Engineering background "MUST HAVES": - Understand med device product development and process around it. - Concept and feasability work, concept - Understand the stage gate process, concept through commercialization - Good understanding of leading a team - Exp. with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems is required - Capital Equipment Exp. (Chemical exp., Class II devices, disposables, software) Duties/Responsibilities: - Managing about 10 projects at any one time. This role would manage 1 NPI or multiple smaller NPI's - Size and scope (3 yrs. 12.5 million project with clinical trials OR smaller ones could be 6 months software upgrade projects) - 8-10 person team size - Collaborates and interfaces extensively in and outside R&D, both within and outside the company. Works effectively with multiple diverse technical and business functions, and uses tact and discretion to resolve conflicts and for issue escalation. Displays solid written and verbal communication and presentation skills, and communicates effectively with customers, multiple teams and diverse stakeholders at all levels - Ensures financial, technical design, quality, and project management accountability for resources and results; works with other teams, Program managers and leaders to achieve strategic Systems goals and integration needs; ensures highest level of global compliance, quality, and ethics in conjunction with the Code of Business Conduct and other Company policies. Recommends basis for SOP exceptions; applies broad understanding of program needs & impact - Executes short and long term objectives, with moderate impact to division strategy with limited impact to corporate strategy. Working through diverse staff, leverages technical opportunities for business advantage - Accountable for overall outcome of programs or projects through influence of indirect staff and multiple teams to achieve system design expectations and integration goals. Support staff, Temps, and Outsourced staff, working on a direct and indirect basis. Administrative management includes: effective work assignment, quality oversight, contract management (as applicable), and budget planning, according to signature levels designated by Corporate Finance - Resolves problems and makes decisions requiring Senior to Principal technical depth/breadth with moderate business (cross function/organizational) understanding of complex tactical business needs - Serves and is recognized as the subject matter expert for the Program and validates all technical components and results; assumes short term program risks resulting in long term impact - Works in concert with operational management, translates corporate and divisional strategies to program/project group to contribute to the overall strategic direction of the Program, Department, and Division - Works on "fixed", time-delimited platform initiatives, typically with development cycles under 5 years Location: Boston, MA. or Remote Start Date: ASAP! Duration: Direct Hire

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