Senior Principal R&D Engineer, Electrical

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
  
  
  
  

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation: The compensation range for this position is $116,734 - $175,101. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.
  
  
  
  

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Visit us on Coloplast.com.

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Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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