The Global R&D Program Manager, Capital Equipment, will be responsible for leading global R&D teams in the execution of product development program(s) and will support the development of the Divisional program strategy. The Program Manager overseas all mechanical, electrical, and software aspects of embedded system development by managing direct staff and utilizing external spec developers and suppliers.
• Serving as the technical leader and project manager for significant capital equipment development projects. The ability to manage several simultaneous projects is a requirement.
• A solid understanding of core engineering principles, fundamental circuit design (analog and digital), simulation, test and measurement equipment.
• Experience with Medical Device Capital Equipment from specification to production, design for manufacturability and cost.
• Create design documentation and test plans to evaluate technologies and verify product functionality against requirements in compliance with the Cook Quality System, regulatory requirements, and industry standards.
• Produce full DMR and DHF documentation for transfer to test/manufacturing
• Be responsible for all software development related to capital equipment.
• Manage internal and external resources to meet the design, build, test and manufacturing criteria. Review vendor deliverables for accuracy and compliance to Cook quality system requirements.
• Work with multidisciplinary teams to deliver device solutions and products ready for pre-clinical or clinical trials.
• Fosters relationships and collaborates with other functional stakeholders
required for the successful implementation of the program
• Must have effective negotiation skills
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent analytical and problem solving skills
• Ability to remain calm and receptive in fast paced situations
• Highly effective goal-setting and implementation skills
• BS in Electrical Engineering, Biomedical Engineering, or related field. MS or PhD is preferred.
• 7-10 years of engineering work experience in the medical device field
• Experience in medical device product development under 21 CFR 820, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Experience in project, program and portfolio management in a complex new product development environment
• Working knowledge of design for manufacture and test.
• Experience with IEC/ISO standards for electrical safety and electromagnetic compatibility for medical devi
Physical Requirements/Work Environment:
• Willingness and availability to travel on company business (approx. 20%)