Process Development Mgr, 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:

• Manage development of manufacturing processes and setting up production facilities for existing and new light based single use and re-usable medical instruments in coordination with engineering, quality, manufacturing, marketing and other company departments;
• Lead design reviews for manufacturability and low-cost production of components, sub-assemblies and complex medical instruments through all development phases from design input through verification and validation to manufacturing transfer stages;
• Assure products are manufactured to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others;
• Assist in managing technical files and design history files, including necessary documentation to support product regulatory approval and manufacture;
• Assist in developing of IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability and costs requirements.

• Education requirements
• MS in Mechanical or Optical Engineering or related field
• Strong knowledge of US and global regulatory requirements for medical devices
• In-depth expertise in Manufacturing processes and production Quality Control systems
• Solid project management skills, experience in reporting and presentations
• Advance skills in AutoCAD and SolidWorks
• Experience requirements
• 10+ years of work experience in development and manufacturing of light and imaging based medical
• instrumentation and products, with at least 5 years managing experience within a company operated under ISO 13485 and FDA protocol all phases of Design Controls;
• Work within cross-functional engineering, manufacturing and quality control teams with responsibilities of defining specifications, test protocols, conducting performance testing, design for manufacturing, development of manufacturing process flow charts, failure mode analysis, and making reports for single use and re-usable medical instruments;
• Management and technical experience designing and implementing in manufacturing environment necessary automation tools and fixtures for optimization of assembling and testing processes, including writing work instructions;
• Successful records of managing product prototyping for pre-clinical and clinical studies, communication with medical practitioners for evaluation and implementation of corrective actions.

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