Position Overview

The R&D Electrical Engineering Systems Manager will lead and supervise the team within the electrical engineering department that is responsible for the design of Intravascular Lithotripsy (IVL) systems and late-stage development of medical electronic products.  Responsibilities include design verification, product type testing, design transfer to manufacturing, and providing technical support to other departments including regulatory affairs, quality assurance and operations.  The Manager will mentor and provide technical leadership to the group in support of company goals and objectives.

Essential Job Functions

• Manage, lead, and mentor engineer(s) and/or technician(s).
• Lead late-stage cross-functional project activities from development through commercial release of product and beyond.
• Lead R&D activities for expansion of product into new global geographies.
• Support a variety of development and engineering activities with focus on IVL systems and generator electronics design and development.
• Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes.
• Ensure that development activities are properly documented through lab notebook, history file, and other records.
• Provide technical support to other departments including regulatory affairs, quality assurance, and operations as required.
• Coordinate cross-functional alignment and support for program success.
• Manage outside vendors and contractors providing products or services.
• Identify issues and recommend solutions for products in development.
• Contribute ideas to new products, as defined by product specification requirements.
• Develop test methods, acceptance criteria, and test equipment for all stages of product development.
• Ensure that products satisfy acceptable quality standards and customer needs with consensus from cross-functional groups.
• Review and approve documents as specified in Document Control SOP.
• Compile the Design History File and conduct design reviews in compliance with Design control procedures.
• Ensure that products have capable manufacturing processes, and that process verifications and validations are completed.
• Interact with cross-functional groups to ensure that products are compatible with other products in the intended system and have met all requirements per the design control process.
• Other duties as assigned.

Requirements

• Bachelor’s Degree in Electrical Engineering and a minimum of 10 years’ experience in the development of medical electrical equipment, including 3+ years’ experience in leading projects in all phases of product development
• 2+ years’ experience managing direct reports
• Experience with EN60601-1 and collateral standards as they apply to medical electrical equipment
• Experience with medical electrical equipment type testing requirements and process.
• Experience with EMC requirements and testing
• Experience with software lifecycle management requirements, processes and standards such as EN62304 and FDA guidance documents
• Experience with lasers and pulse discharge systems is a plus
• Effective communication skills with all levels of management
• Ability to work in a fast-paced environment, managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements
• Employee may be required to lift objects up to 25lbs