This position involves leading program management of next generation of company products.  This involves cross functional communication with quality, operations, marketing, and sales, as well as leading product development teams of internal and external resources.  

Company Profile

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

Primary Responsibilities: 

• Lead cross-functional technical teams to develop and commercialize new products that support business initiatives
• Lead communication with cross functional stakeholders to review project status and resource needs
• Support product launches in partnership with Operations, Marketing, Sales & Clinical Training
• Oversee internal and external design resources including work with contract manufacturers
• Develop and manage policies, process and procedures that affect program management
• Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
• 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
• Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations.
• Attend patient cases and support customers as assigned

Required Qualifications:

• Bachelor’s degree in engineering or related field
• Experience managing the process of designing, developing, and delivering innovative medical technology
• Experience interfacing and communicating with cross functional stakeholders
• Experience establishing and building highly effective product development teams consisting of internal resources, contract resources, and large external vendors
• Experience managing timelines, budgets, and identifying critical path constraints
• Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing

Preferred Qualifications: 

• Master of Business Administration (MBA) or a Master’s degree in engineering or related field
• Experience leading multiple active implantable medical product development programs
• Experience leading cross functional communication and resource planning
• Extensive experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
• PMP Certification