This position involves synthesizing customer needs, business needs, anatomical constraints, and technology expertise into product development and implementation plans for the next generation of company products.  This position will focus on implantable product design and miniaturization as well as support continuation engineering as required. 

Company Profile

Client is a growing medical device company that offers innovative implantable devices.

Primary Responsibilities: 

• Technical lead on product development of implantable products
• Lead product design reviews for products in development as well as continuation
• Create, control and store engineering drawings (CAD, SLDWKs, ProE, etc.)
• Lead and/or support product level risk management activities in compliance with ISO 14971
• Work with contract manufacturers on design for manufacturability and process validation activities (IQ/OQ/PQ)
• Support pre-clinical studies and consider anatomical constraints for product feasibility
• Assure compliance with industry applicable standards for medical devices
• Generate and approve design history file documents, device master record documents and engineering change order records
• Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
• Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations
• Provide continuation engineering support for products as assigned
• Support new product launch planning in partnership with Operations, Marketing, Sales & Education

Required Qualifications:

• Bachelor’s degree in a mechanical engineering or related field
• Experience designing, developing, and delivering innovative medical technology (9+ years).
• Experience as technical leader on product development teams consisting of internal and contract resources
• Experience as primary point of contact for external design / manufacturing vendors
• Aptitude for understanding anatomy to drive product design
• Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing

Preferred Qualifications: 

• Master’s degree in mechanical engineering or related field
• Experience with miniaturization of active implantable medical devices
• Experience with manufacturing process validation activities (IQ/OQ/PQ)
• Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
• Understanding of sterilization validation and the corresponding standards
• Understanding of biocompatibility material selection and testing