Senior Product Development Mechanical Designer
Vapotherm - Exeter, NH

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Sr. Product Mechanical Designer/Engineer is responsible for mechanical design support for new product development and sustaining engineering. This role provides leadership and works closely with other functional leaders in the company to ensure that programs yield the quality, cost and performance objectives on schedule, within budget and in compliance with ISO 13485 and FDA QSR for medical devices

Position Responsibilities
Project Management and technical leadership in mechanical design including program schedule, cost of goods sold and budget
• Mechanical part design (Plastic and metal)
• Injection mold part design & tooling (Design Transfer)
• Develop solid model with SolidWorks systems
• Develop print/ purchase specifications and acceptance criteria
• Conduct tolerance analysis of components and assemblies
• Provide technical guidance in vendor selection
• Formulate verification & validation plans; Develop protocols
• Develop and process engineering change orders (ECOs)
• Technical expertise in design reviews
• Support design and process FMEAs
• Conduct failure investigations on component failures and NCMRs
• Support vendor selection and supplier audit in areas of expertise (Injection Molding)
• Assist mold suppliers with manufacturing process validation and troubleshooting
• Coordinate and lead technical resources assigned to the programs
• Participates in the evaluation and selection of new technologies and vendors
• Provide routine program communications and management updates
Position Requirements
BS/MS Mechanical Engineering, Biomedical Engineering or Chemical Engineering degree required
• Minimum seven years experience with BS degree or five years minimum experience with masters degree as Product Design Engineer, Mechanical Engineer or Product Development Engineer in the medical products or related industries
• Strong background and knowledge in Medical Device Design Control
• Must be able to handle a variety of projects at the same time
• Good verbal and written communication with all levels of technical and operating management.
• Broad knowledge and use of medical devices
• Knowledge of GMP’s, current FDS Medical Devices legislation and regulations
• Ability to travel up to 25%

Vapotherm - 21 months ago - save job - copy to clipboard