Location(s): United States; Massachusetts; Marlborough
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Role Summary: The Project Leader is responsible for leading projects and their corresponding project teams. In addition, this position is accountable for achieving quality objectives, creating/meeting development schedules and project budgets, as well as communicating program status and escalating issues when appropriate to facilitate transparency.
Essential Responsibilities: • Leading cross-functional program activities for hardware/equipment, single-use consumables, and/or cost reduction projects with responsibility for timely completion within budget • Managing and optimizing project plans, product/project risk, project budgets, and resources/task assignments • Working closely with all support functions, effectively facilitating cross-functional decision making to deliver effective and timely new product development process results • Ensuring compliance with Design History File (DHF) and other QMS requirements • Managing customer critical-to-quality (CTQ) objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position • Complete all planned Quality & Compliance training within the defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones • Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications/Requirements: • BS Degree in Computer Science, Mechanical, Electrical or Biomedical Engineering • 5 years relevant project management/technical leadership • Demonstrated leadership of cross-functional project teams and an ability to drive project design plans to completion • Familiarity with ISO, FDA and other regulatory standards
Desired Characteristics: • Strong written and verbal communication skills • Experience with conflict resolution • Experience with stage gate development process • Project management certification • Experience managing or overseeing global resources and/or projects • Previous work experience with strong ability to influence in a matrixed-management/leadership environment
Locations: United States; Massachusetts; Marlborough
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