Research and Development Manager, Capital Equipment

Cook Medical - Bloomington, IN

Full-time - Mid Level

Hybrid - Bloomington, IN

Miscellaneous Manufacturing

About the position

The R&D Manager, Capital Equipment will be responsible for overseeing R&D project team(s) in the execution of product development projects to support the project related strategy. They will be responsible for development of durable medical capital equipment from early phase needs assessment through to initial commercialization. The successful candidate should demonstrate excellent communication skills and a proven ability to work strategically with multiple stakeholders to foster collaboration. This role is a hybrid position located out of our Bloomington, Indiana location.

Responsibilities

• Serves as technical leader and project manager for significant medical capital equipment development projects.
• Responsible for overseeing all software, hardware and electrical or system development and compliance of design documentation to the QMS and international standards related to medical capital equipment.
• Fosters relationships and collaborates with other functional stakeholders required for to develop the project related strategy associated with capital equipment and the successful completion of development projects.
• Manage schedule, costs/budget and resources for project(s) assigned.
• Actively engage with Key Opinion Leaders (KOL's), physicians and product managers to ensure user and business needs are appropriately addressed.
• Technical responsibility for all R&D activities assigned.
• Identifying new vendors and strategic partners for product development and component/subassembly supply.
• Maintain and improve high standard of durable medical capital equipment and device engineering.
• Manage the development of the IP portfolio for their area of responsibility.
• Ensure team/teams deliver quality designs and compliant documentation in a timely manner.
• Mentoring, coaching and development of direct reports to attain best performance.
• Works with other R&D managers and leaders to ensure sharing of R&D best practice.
• Foster and maintain a workplace culture respectful and supportive of individual differences.
• Ensure effective communication of project progress and risks to all relevant stakeholders.
• Must work, interact and communicate effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.

Requirements

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related field.
• Minimum 7 years' relevant experience in the area of development of durable medical capital equipment with at least 3 years gained in roles involving managing of a team or teams.
• Experience in project, program, and portfolio management in a complex product development environment.
• Strong technical writing and stakeholder management.
• A solid understanding of core engineering principles, fundamental circuit design (analog and digital), software, simulation, test and measurement equipment.
• Must have good understanding of IP process.
• Experience with IEC/ISO standards for electrical safety and electromagnetic compatibility for medical devices.
• Experience in medical device product development under 21 CFR 820, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Excellent problem-solving skills.
• Ability to remain calm and receptive in fast paced situations.

Nice-to-haves

• MS or PhD in related field.
• Experience with durable medical capital equipment, including demonstrated ability to develop products from concepts through to commercialization.