Principal Firmware Engineer

Principal Firmware Engineer

Location:

Minneapolis, MN, US

Job Family:
Research & Development

Country/Region:
United States

The Principal Firmware Engineer has deep expertise in active implantable medical devices. This role leads the design, development, testing, and optimization of embedded firmware to ensure the safety, reliability, and performance of life‑critical medical technologies. The role owns firmware architecture and plays a leadership role in product development, regulatory compliance, and process improvement.

• Lead the design, development, and testing of firmware for active implantable medical devices with strict power and size constraints
• Own firmware architecture, system design, and technical decision‑making
• Collaborate cross‑functionally with hardware, systems, software, and regulatory teams
• Develop and validate communication protocols (e.g., Bluetooth Low Energy, proprietary RF) for secure device connectivity
• Optimize firmware for low power operation to maximize device longevity
• Perform code reviews, static/dynamic analysis, and ensure software quality and reliability
• Support development of non‑production tools/software for testing and validation
• Ensure compliance with industry standards (ISO 13485, IEC 62304, FDA regulations)
• Implement cybersecurity best practices, including encryption and secure data transfer
• Decompose system‑level requirements with Systems Engineering and Program Management
• Lead and participate in design reviews across the team
• Support clinical trials and post‑market activities through firmware updates and performance analysis
• Support the full product lifecycle from concept through verification, validation, transfer to manufacturing, and post‑market support
• Apply rigorous risk management practices including hazard analysis and FMEA
• Contribute to and improve Standard Operating Procedures (SOPs)
• Ensure development processes align with quality systems and regulatory expectations
• Promote engineering best practices and continuous improvement within R&D
• Strengthen Software Engineering processes and cross‑functional collaboration
• Ensure adherence to ethical standards, regulatory requirements, and company policies
• Other duties as assigned
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Med Tech Code of Conduct, and company policies.

• Bachelor's degree in electrical engineering, computer engineering, computer science, or related field. Master's degree in related field is preferred.
• 8+ years of embedded firmware development experience
• 5+ years developing firmware for active implantable medical devices

• Strong expertise in C/C++ programming for resource‑constrained systems
• Hands‑on experience with RTOS (Real‑Time Operating Systems)
• Experience with medical device regulations (FDA, ISO 13485, IEC 62304)
• Experience with low‑power wireless communication (e.g., BLE)
• Experience with cryptography and secure key implementation
• Experience using development tools such as Git Hub and Azure Dev Ops
• Experience with static analysis, unit testing, and code quality tools
• Strong understanding of embedded systems architecture and hardware‑software integration
• Proficiency with debugging tools (JTAG, oscilloscopes, logic analyzers)
• Knowledge of cybersecurity principles for connected medical devices
• Ability to work in a highly regulated, safety‑critical environment
• Excellent problem‑solving skills and attention to detail

• Familiarity with Agile development methodologies

• Health and Wellness:
  Comprehensive medical, dental, and vision insurance plans, company sponsored wellness programs, mental health resources, paid leave of absence for qualifying events, and generous paid parental leave for both birthing and non‑birthing parents.
• Financial Security:
  Competitive 401(k) plan with company match that vests immediately, financial planning services, and corporate discount programs.
• Work‑Life Balance:
  Generous paid time off, flexible work hours, and flexible work arrangement options.
• Professional Development:
  Opportuniti…