Project Engineer (Medical Devices)

Location: Mansfield, Massachusetts, United States

Company

hirify.global is an IT staffing and services company providing staff augmentation, talent management, permanent placement, and vendor management services to Fortune 500 and mid-size organizations.

What you will do

• Contribute to the development and maintenance of intermittent pneumatic compression systems for deep vein thrombosis prevention.
• Design and evaluate electronic hardware and embedded software implementations throughout the product life cycle.
• Write and review electronics and software requirements, conduct technical and design reviews, and drive solutions to technical issues.
• Prepare verification and validation protocols, technical reports, schedules, and project status updates.
• Execute design controls, risk management, requirements tracing, and Design History File documentation.
• Lead and influence offsite and third-party design engineering resources while collaborating with quality, regulatory, manufacturing, marketing, and clinical teams.

Requirements

• Bachelor’s degree in Electrical Engineering or Biomedical Engineering with an electrical engineering concentration.
• At least 5 years of relevant medical device experience with a bachelor’s degree, or at least 3 years of relevant medical experience with a master’s degree.
• Experience with PCB design software such as PCAD, PADS, OrCAD, or Altium.
• Knowledge of electrical and medical device safety standards, including FDA, ISO, IEC, EN, UL, Intertek, and TUV requirements.
• Experience with embedded systems requirements development, management, and tracing, as well as GMP, FDA QSR, design controls, and risk management.
• Strong written, verbal, presentation, statistical analysis, and project documentation skills; familiarity with Minitab or equivalent tools and Microsoft Office applications.

Culture & Benefits

• Contract engagement in a dynamic, cross-functional engineering environment.
• Paid vacations, holidays, and personal days.
• Medical, dental, and vision insurance.
• 401K retirement savings plan, life insurance, and disability insurance.