• Collaborate with the systems and development teams to translate high-level customer needs into technical options and analyze the tradeoffs and business impact.
  • Define requirements, test acceptance criteria, develop test methods, and create test protocols/reports as part of the new product development process.
  • Build prototypes, products, and systems for testing, along with set up and run laboratory simulations.
  • Lead design control activities and design history file implementation per FDA & CE mark standards.
  • Work with software, firmware, hardware, and wireless communications.
  • Lead a team in an Agile development environment.

Qualifications

  • A minimum of a Bachelor’s degree in Electrical Engineering or a related science/engineering degree is required.
  • An Advanced Degree is preferred.
  • A minimum of 8 years design/product development related experience is required.
  • Experience designing, developing, and launching product in a regulated environment is required.
  • Track record in R&D delivering solutions with complex system components and architecture is required.
  • Experience working with software, firmware, and hardware is required.
  • Experience working with wireless communications is required.
  • Experience managing a globally based team is highly preferred.
  • Robotics experience is preferred.
  • Knowledge of ISO 13485, 60601, etc. is preferred.
  • Strong electrical design and analysis skills, including an understanding of electrical systems and subsystem interface to overall system design are required. This will include digital, analog, and mixed signal technologies. Knowledge of electronic manufacturing is also key to this role.
  • Experience translating high-level customer needs into technical options and analyzing the tradeoffs and business impact required.
  • Experience with defining requirements, test acceptance criteria, developing test methods, and creating test protocols/reports is required.
  • Experience building prototypes, products, and systems for testing, along with setting up and running laboratory simulations is preferred.
  • Experience with leading design control activities and design history file implementation per FDA & CE mark standards for medical devices is preferred.
  • Experience with capital equipment and disposable medical devices is preferred.
  • Experience working with schematics, layouts, and design analysis is preferred.
  • Experience working in an Agile development environment is preferred.
  • Ability to explain (both written and verbal) complex technical issues to less experienced team members, quality engineers, marketers, and technical writers is required.
  • Requires excellent collaboration and teaming skills to work with manufacturing engineering and suppliers to understand the considerations associated with Design for Manufacturing (DFM) and working with other team members and consultants to produce prototypes and optimize designs for manufacturability.
  • This position will be located in Boston, MA or Warsaw, IN and may require up to 20% travel depending on business needs.