Project Manager, Surgical Device Product Development - See more at:

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Job ID Number: 2013006400 Location: USA - MA - Boston Job Description This Project Manager will be a member of the Covidien R&D team working to develop and support Covidien’s next generation minimally invasive surgery platform. This Project Manager will work closely with program management, subsystem technical leads, and other engineers to manage and coordinate engineering activities. S/he will be responsible for project management activities for one or more groups dedicated to specific platform subsystems. This person will ensure that his/her engineering teams: Are efficient, effective and well-coordinated. Have clear priorities and goals. Develop and tracks to schedules. Deliver quality designs according to process. ESSENTIAL FUNCTIONS: The Project Manager is responsible for engineering project management: Coordinate, develop and track schedules, plans, tasks, and priorities. With technical leads, develop and manage R&D process and tools for specific subsystems. Assist with design, selection and implementation of tools and processes. Manage product development process for subsystems which include software and hardware. Experience with IEC 62304 is required. Support engineering teams to follow effective process. Promote communication between multiple platform teams and disciplines. Assist team to comply with requirements for developing safe, regulated medical devices. Ensure that process is aligned with other R&D teams and meets policies set by Covidien. Manage documentation and other cross-functional deliverables. Manage and organize content for the Design History File (DHF). Organize and manage system BOM structure (with input from technical leads and program management). Assist program management with developing and managing to budgets. Anticipate and mitigate risk points. Make tradeoffs between time, schedule, cost, and quality (when appropriate), while meeting safety and regulatory requirements. Education required/ preferred: A minimum of BSc. in Engineering, Computer Science, or equivalent. Work Experience: Minimum of 6 years of experience managing complex, full-lifecycle engineering projects At least 2 years with cross-functional projects involving both custom software and custom hardware Substantial responsibility for managing activities, schedules and resources Demonstrated skills in managing priorities and making complex technical and business tradeoffs Experience coordinating multiple teams to execute concurrent, interdependent projects Skills/Competencies: Intimately familiar with project management concepts (PMI, schedule/cost/quality tradeoffs, schedule and resource planning, etc.) Experience with highly regulated and/or safety-critical systems is required (medical device experience strongly preferred) Expert knowledge of software and hardware engineering management, both tools and process (project tracking/scheduling; bills of materials; document management; issue/bug tracking; configuration management; integration/release testing; etc.) Solid understanding of structured product development (requirements-driven engineering, requirements documentation, rigorous verification, DFMEA, etc.) Comfortable with a range of project management methodologies (sequential/waterfall, Scrum, Agile, etc.) Well-versed in R&D, product development, and clinical/regulatory process (e.g. IEC 60601, IEC 62304, ISO 14971, ISO 13485) Preferred Experience: Electromechanical systems involving custom electronics (PCBs), moving mechanical mechanisms, and embedded computing are strongly preferred Experience implementing safety-critical products Technical skills (mechanical, electrical, software) are desirable Experience with controls and/or robotic systems Knowledge of surgery/MIS Other Skills: Fluency in English required (German a plus) - See more at:
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