Hardware/ Electrical Engineer
Vapotherm - Stevensville, MD
Vapotherm Inc. is a medical device manufacture of respiratory equipment that delivers conditioned medical gas to patients in hospital and home care markets. The Hardware/ Electrical Engineer is responsible for the coordination electrical/ hardware engineering projects ranging from quality improvements, sustaining and new product development activities. This position requires experience with CFR 820 part 11 compliance with emphasis on verification & validation. The ideal candidate must have experience in both electromechanical, firmware and mechanical design.

Position Responsibilities

• Expert and technical lead on electrical engineering issues, circuit design and hardware integration
• Lead outside design firms on electrical design
• Coordinate and lead compliance testing with outside Test Labs
• 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
• Present to the Senior Management team on the program status
• 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 are similar technology in Electrical Engineering with progressive responsibilities including managing contract design firms and test houses (compliance testing)
• Must have experience with Document Management systems

Vapotherm - 12 months ago - save job - block
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