Coloplast Corp

Principal Firmware Engineer

Coloplast Corp • $116K — $175K *
Minneapolis, MN 55407In-Person
Healthcare
8 - 10 years of experience
Yesterday
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in electrical engineering, computer engineering, computer science, or related field; Master's preferred.
  • 8+ years of embedded firmware development experience.
  • 5+ years developing firmware for active implantable medical devices.
  • Strong expertise in C/C++ for resource-constrained systems.
  • Hands-on experience with Real-Time Operating Systems (RTOS) and medical device regulations.

Responsibilities

  • Lead design, development, and testing of firmware for active implantable medical devices.
  • Own firmware architecture and system design decisions.
  • Collaborate with cross-functional teams including hardware, systems, and regulatory.
  • Develop and validate secure communication protocols like Bluetooth Low Energy.
  • Optimize firmware for low power to enhance device longevity.
  • Perform code reviews and ensure software quality and reliability.
  • Support the complete product lifecycle from conception to post-market activities.

Benefits

  • Promote engineering best practices and continuous improvement.
  • Support compliance with quality systems and regulatory expectations.
  • Strong emphasis on ethical standards and professional conduct.
Full Job Description
The Principal Firmware Engineer has deep expertise in active implantable medical devices. This position leads the design, development, testing, and optimization of embedded firmware to ensure the safety, reliability, and performance of life-critical medical technologies. This role owns firmware architecture and plays a leadership role in product development, regulatory compliance, and process improvement.

Major Areas of Accountability
  • 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
  • Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
  • Other duties as assigned


Basic Qualifications
  • 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


Required Knowledge, Skills and Abilities
  • 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 GitHub and Azure DevOps
  • 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


Preferred Qualifications
  • Familiarity with Agile development methodologies


About Coloplast Corp

Coloplast Corp is a Danish multinational company that develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care. The company was founded in 1957 and is headquartered in Humlebaek, Denmark. Coloplast operates globally with production facilities in Denmark, Hungary, China, and the United States. The company's products are sold in more than 140 countries. Coloplast is committed to improving the quality of life for people who have intimate healthcare needs. The company's mission is to make life easier for people with intimate healthcare needs by developing products and services that make a difference to their lives.
Learn more about Coloplast Corp
Size
12,000 employees
Industry
Healthcare
Founded
1978
* Ladders Estimates

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