Sr Manager, Electrical Engineering - Instruments & Accessories

Intuitive • Sunnyvale, CA

16h

About The Position

Primary Function of Position The Sr Manager, Electrical Engineering - I&A is responsible for leading the design and implementation of control hardware and sub-systems for new energy-based surgical equipment and surgical instruments. This responsibility includes functional management of the electronic hardware development team and oversight of the entire product development process, from the evaluation of early feasibility study prototypes through the formal product verification and validation activities. Responsibilities for development continue until the products are approved by the regulatory agencies in the targeted geographies and fully released to market. This position provides design and analytic assistance to other development teams to help them understand the energy-based technologies, and to guide the design of instruments and accessories that enhance or support the energy-based equipment used during surgical procedures. This position also maintains awareness and interest in developing research and technologies related to energy based surgical equipment and in the evolution of regulations, standards and guidance documents that impact the regulatory approval process.

Requirements

• 8 years of professional experience as an electrical engineer.
• 5 years of experience managing engineering personnel and other technical resources.
• Working knowledge and experience with the recognized consensus standards pertaining to electronic surgical equipment, specifically including IEC 60601-1, 60601-1-2, 60601-2-2.
• Strong knowledge of electronic circuit design, high voltage circuit design, and energy control algorithms with an emphasis on design for manufacturability and reliability.
• Creative and proactive leader with a passion for coaching, developing and mentoring employees throughout the organization.
• Excel in a high-energy, small-team environment.
• Demonstrate excellent verbal and written communication skills.
• BS degree in Electrical Engineering with 10 years of proven experience bringing electronic medical capital equipment through the entire development process and release to production.

Nice To Haves

• Experience implementing microcontroller and FPGA based control systems on medical device products in conformance with IEC 62304.
• Possess embedded C programming capabilities as well as hardware, software, and mechanism integration skills.
• Strong understanding of the energy based surgical equipment market to be able to assess complex trade-offs and risk mitigations to ensure programs remain on schedule and deliver the intended performance.

Responsibilities

• Lead a team of electronic development engineers and directly contribute to the design of new energy based surgical systems through the entire development process from initial feasibility evaluations to completion of the design control process and release to production.
• Work with direct reports to establish impactful objectives and goals consistent with overall program goals.
• Provide oversight and directly contribute to the creation of design control documentation describing risks, requirements, specifications, and verification/validation test protocols.
• Be an expert in the application, market needs and risks associated with the use of high frequency and ultrasound energy for surgical procedures.
• Have a strong understanding of the existing energy based surgical equipment intellectual property landscape and drive efforts to develop innovative new intellectual property.
• Maintain a close working relationship with the regulatory affairs team members to support the development of regulatory strategy for energy-based products and to provide technical input on the content of submission documents.
• Provide electrical engineering sustaining support for resolution of supply chain, manufacturing and field issues
• Assist with planning, staffing, budgeting and project/program cost tracking
• Lead by having a breadth of technical knowledge that enables a top-level view of the entire project and act as an interface between the various functional specialties to drive towards an optimal product solution.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager