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 - block
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