Director of Engineering - Sustaining
Vapotherm - Exeter, NH

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Vapotherm Inc. is a medical device manufacture of respiratory equipment that delivers conditioned medical gas to patients in hospital and home care markets. The Director/ Manager of Sustaining Engineering is responsible for the coordination and management of sustaining (product life-cycle) activities ranging from quality improvements, component obsolescence replacement, cost reduction programs and minor product development. This position requires experience with 21 CFR 820 compliance with emphasis on verification & validation. This position will manage 3-5 engineering resources and multiple projects. The ideal candidate must have experience in both electromechanical, firmware and mechanical design.

Position Responsibilities

• Coordinate and prioritize engineering activities required to support the product life cycle
• Expert and technical lead on Electrical Engineering issues
• Lead, develop & execute Verification & Validation plans
• Conduct and lead failure investigations
• Ensure document management and design control compliance
• Manage and communicate with external design firms
• Conduct and manage structured design reviews
• Assist in re-engineering SOPs and process
• Write design requirements and specifications
• Train the department on processes and procedures
• Present program status to the Senior Management team
• Mentor and lead Engineers and Designers
• Coordinate lab activities
• Manage R&D communication with Contract Manufactures on key programs

Position Requirements

• Must have a minimum of 10 years experience in a Medical Device company of similar technology and progressive experience with managing engineering resources
• 8-10 years experience in Electrical Engineering with progressive responsibilities including managing contract design firms and test houses (compliance testing)
• Must have experience with Document Control Systems and procedures

Vapotherm - 17 months ago - save job - copy to clipboard