Principal Mechanical Engineer, Medical Instruments - Marlborough, MA

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Duties

• Lead development of complex medical instruments through all development phases from design input through verification and validation to manufacturing transfer stages and in coordination with overall system requirements.
• Assist in developing IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability, and cost requirements.
• Develop product specifications in coordination with marketing, customers and other company departments.
• Coordinate technical part of transfer of company products and instruments to customers or distributors, including analysis of customer complaints and recommendations.
• Provide cost reduction program for medical instruments.
• Assure that products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical products and others.
• Assist in development and maintaining design history file and other documentation to support product regulatory approval and manufacture.

Education requirements

• MS in Mechanical Engineering or related field
• Strong knowledge of US and global regulatory requirements for medical devices
• Solid project management skills

Experience requirements

• 8+ years of work experience in research and development designing light based medical instrumentation and products, with more than 5 years in senior position of supervising technical part of development projects with internal and external teams, development partners and suppliers within a company operated under ISO 13485 and FDA protocol in all phases from design input to transfer to production.
• Innovative approach in development of multi-functional medical instruments including mechanical / optical / electronic components and lab experimentation with miniature catheters.
• Coordination of development teams, work within strict time schedules and budget boundaries, managing multiple suppliers and development partners, negotiating specifications and technical terms of the projects.
• Successful records of rapid prototyping for pre-clinical and clinical studies.