Manager, Sustaining Engineering

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Position Summary:

The Engineering Laboratory Manager leads the Engineering Lab team in the maintenance, design transfer, and continuous improvement of company's cutting-edge medical devices. This leadership role oversees the technical team that provides long-term engineering sustaining support of released products, as well as supporting prototyping and testing efforts for products in development. As a team leader, they are responsible for the development and growth of skilled technicians and engineers, along with the identification, planning and maintenance of the techniques, processes, systems, and tools they use every day to optimize team quality, efficiency, and consistency.

Job Duties and Responsibilities:

• Lab Team Ownership: Oversees and leads the Engineering Laboratory team in supporting both new development and post-release sustaining of the company's medical devices; includes failure analysis, design verification testing, component management, production/procurement support, design improvements, and releasing new and updated engineering design
• Team Leadership & Growth: Provides mentorship and guidance to Laboratory Technicians and Engineers, assisting in their technical development and strategically growing and diversifying skills and team composition to best support the company's success
• Manage and Monitor Resources: Oversees and actively manages Engineering Laboratory resources to ensure they are efficiently applied to both projects and smaller supporting activities; continuously evaluates team, outputs, and workload to proactively identify and communicate resource needs and schedule impacts, adjusting plans and priorities as needed
• Reactive Work Management: Ensures timely resolution of engineering support escalations from other departments, as well as externally sourced escalations from vendors
• Sustaining Change Planning and Oversight: Leads engineering change control efforts for released designs, chairing change control activities and cross functionally coordinating with Production, Procurement, and Manufacturing Engineering as necessary to ensure success
• Laboratory Systems Ownership: Provides leadership on and direction for the systems (standards, processes, checklists, and tools) used by the Engineering Laboratory team; continuously monitors and manages the performance of the Engineering Laboratory team and systems against set goals
• Technical Expertise: Maintains strong technical skillset to evaluate, guide, and continually improve the team's produced work; ensures that work quality meets design standards and industry best practices
• Inter-team Collaboration: Partners with other departments such as Procurement, Manufacturing, Service, Software & Hardware Engineering, Regulatory Affairs, Quality Assurance, and Supplier Quality Engineering to ensure they are supported as needed
• Regulatory and Process Compliance: Ensure the team's processes, trainings, and outputs align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, etc.) and processes; supports internal and external audits from FDA and Notified Bodies
• Perform other duties as assigned

Qualifications:

Knowledge, Skills, and Abilities:

• Comprehensive knowledge of engineering team leadership, staff development, and development of engineering procedures, checklists, and work instructions
• Comprehensive knowledge of PCB design from concept through manufacturing transfer and post-release support; includes Design-For-Manufacturability and Test (DFM/DFT) analysis
• Thorough knowledge of electrical engineering principles, including failure analysis, reliability engineering, component selection, and risk-based decision making.
• Thorough knowledge of common embedded electronic circuits such as DC-DC converters, embedded microcontrollers, memory interfaces, sensors, and other technologies
• Thorough knowledge of regulatory compliance and Quality Management Systems (QMS) required for Medical Device
• Thorough knowledge of the entire hardware development life cycle including development, testing, change control, deployment to production, and maintenance
• Ability to plan, organize, and exercise sound judgment; communicates plans and schedules well, motivate and lead employees, and collaborate with other teams
• Ability to clearly assess, articulate, and manage risk with a sense of urgency to meet product requirements, on schedule, and on budget. Must be able to see the big picture, prepare contingency plans, and ensure execution of plans through effective organizational awareness

Education and Experience:

• B. xhyhwjd S. in Electrical Engineering or equivalent worked experience
• Typically has greater than ten (10) years of relevant professional or technical engineering management experience of increasing responsibility and difficulty of assignment
• Experience designing regulated equipment. Ideally this experience is in a medical or similar safety-conscious, highly regulated industry