InnoTECH Staffing is looking to hire a Principal Embedded Software Engineer for a well funded and growing late stage medical device start-up in Waltham, MA.

The Principal Software Engineer provides expertise in the design, development, characterization, and testing of complex software/firmware used to drive and manage complex electromechanical medical devices. In this role you will interface with a strong multidisciplinary team across the full product development life cycle including requirements, risk, implementation and testing activities.

Responsibilities:

• Collaboratively work with System’s Engineering to translate system level requirements into product architectures making tradeoff decisions regarding hardware and software partitioning
• Uses modeling, hardware-in-the-loop simulation and actual devices to develop, debug and test complex systems to meet required performance
• Develop software subsystem architectures aligned to product level requirements and architectures including software requirements definitions and sub-system designs
• Design and develop software/firmware utilizing C and C++ on embedded real time operating systems (RTOS) following company and industry requirements and best practices
• Performs advanced risk analyses using FMEA and fault tree methods. Works with other engineering disciplines to develop, implement, and verify solutions
• Perform software verification including code reviews, writing unit test cases, and running static analysis
• Document system design inputs and outputs using the company's design control and document management system
• Evaluates product performance on an on-going basis and initiates and evaluates required changes to the designs to improve and optimize performance
• Solve complex software issues by analyzing critical factors and recommending corrective or alternative actions
• Ensures adherence to company quality system, product specifications, industry standards, and quality and regulatory procedures and requirements
• Maintains accurate documentation of concepts, designs, drawings, and processes through lab notebooks or other methods

Requirements:

• Bachelor’s Degree in Software or Electrical Engineering. Master’s degree preferred.
• 10+ years Software Engineering experience in the design and development of complex, software driven electromechanical Class II medical devices; Class III experience preferred
• Detailed knowledge of key regulatory requirements included ISO 13485, ISO 14971, ISO 62304 as well as FDA QSR 21 CFR Part 820
• Experience with electronic design control and document management systems preferred
• Ability to work independently with high competency and little guidance.
• Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems
• Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency
• Strong design control and documentation skills
• Strong analytical and leadership skills