Provide mechanical engineering expertise from product prototype and development through commercialization. Design and build medical devices, including proof of concept designs, for systems involving motion with ultrasound imaging and therapy delivery that are electro-mechanical in nature. Provide product design guidance and consultation support on commercialized product.

Responsibilities 

• Design and develop new products, components or accessories, define requirements and support selection of production/commercialization process.
• Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.
• Design, develop and support proof-of-concept and early development prototypes for new technology and features to support product road map.
• Apply Risk Management and Hazard Analysis process to new product designs, product upgrades, and field failures as the product development subject matter expert.
• Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.
• Working within the Product Development Process complete assigned projects with internal team members and qualified external development partners.
• Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding design and development of new product designs and product upgrades.
• Support of the Document Change Notice (DCN) and Change Request (CR) processes per Design Controls – Design Change regulations and internal policies
• Substantiate product design by developing test plans, performing design analysis, making design adjustments, running performance calculations, and maintaining quality standards.
• Subject Matter Expert on all general aspects of mechanical engineering principles as they relate to product development and related tool and fixture design.

Education

• Bachelor in Mechanical Engineering required
• Master in Mechanical Engineering preferred

Professional experience

• 7 years total Mechanical Engineering experience
• 5 years of related design and development experience in medical devices
• FDA Design Controls for medical devices
• EU Medical Device Directive (CE Marking requirements)
• Knowledge and experience with application of Six Sigma statistical analysis and controls
• Understanding and experience in product design and development including the use of tools such as FEA, Risk Analysis, DFMA, GD&T, and DFMEA
• Strong design and documentation skills using the Solidworks CAD application

Knowledge, skills, and abilities

• FDA Design Controls for medical devices
• EU Medical Device Directive (CE Marking requirements)
• Understanding and experience in product design and development including the use of tools such as FEA, Risk Analysis, DFMA, GD&T, and DFMEA
• Design and documentation skills using the Solidworks CAD application
• Experience in material knowledge, molding, and tooling for manufacturing.
• Experience in designing mechanical fixtures to support design and manufacturing.
• Excellent verbal and written communication.
• Proficient with Word, Excel, PowerPoint, and Project.
• Demonstrated ability to deliver results with minimal supervision in a timely manner.
• Ability to collaborate, communicate and coordinate cross-functionally.