Job Description

An industry leading medical device company located North of San Francisco is looking to hire an experienced Engineering Manager or Senior Engineering Manager for their R&D department. The new product development division is developing innovative transcatheter heart valve replacement systems. This role will manage an R&D team of 10+ engineers through product design and development of new catheter delivery systems, accessories, and surgical procedures.

The senior leadership team is seeking an R&D leader with at least 5 years of functional team management experience coaching and developing junior R&D Engineers. This role will also be responsible for managing complex R&D programs and supporting strategic development of the future product portfolio. Demonstrated experience successfully leading development of new catheter-based devices from initial concept design to market release is required. Relocation assistance will be offered to qualified candidates.

Role Responsibilities:

• Manage, coach, and develop a high-performing R&D Engineering team accountable for design and development of innovative medical device products
• Oversee the investigation and evaluation of existing technologies. Guide conceptualization of new methodologies, materials, machines, processes or products.
• Support new product design using a systems engineering approach along with advanced design techniques, prototyping methods, and in-vivo modeling.
• Direct development of new concepts from initial design to market release. Manage feasibility studies of the design to determine if capable of functioning as intended and the design V&V process.
• Manage complex and strategic R&D Programs as well as initiatives to improve design processes, DfM, and DfR.
• Monitor documentation maintenance throughout all phases of research and development and manage external suppliers.

Minimum Requirements:

• BS or advanced degree in Engineering (Mechanical, Biomedical, Material Science) and 10+ years of medical device industry experience.
• 5+ years of experience as a functional team manager managing R&D Engineers.
• Experience working in large, multi-site, matrix organizations.
• At least 4 years of experience in catheter delivery system design and development. 5+ years of NPD experience for cardiovascular catheter devices and implants preferred.
• Strong systems engineering, injection molding, and plastic part design skills and advanced understanding of statistics, functional modeling, design risk analysis and Technical Drawing Reviews.
• Experience managing complex and strategic R&D programs/projects and influencing cross-functional teams/peers.
• Experience integrating Design, Reliability, Manufacturability, and Six Sigma Black Belt principles into engineering projects.

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