Principal R&D Engineer, Systems

The Interventional Urology Principal Systems Engineer is responsible for leading, defining, and evaluating new product development and existing designs by using a systems approach to ensure all products meet the customer requirements, standards requirements, quality systems and global regulations. This role will support all project initiatives for implantable devices while leading efforts to create and/or modify Standard Operating Procedures. The Systems Engineer is a key member of our product development team.

• Technical Leadership
  • Drives the architecture, system design, system boundaries and all associated interfaces.
  • Lead overall requirements hierarchy strategy while establishing performance metrics.
  • Thorough understanding of requirement leveling and tracing.
  • Foster a culture of innovation, technical rigor, and quality compliance.
  • Excellent cross-functional collaboration and communication abilities.
  • Provide guidance, coaching, and training to other employees within job area.
  • Routinely demonstrates strategic thinking and problem-solving skills.
  • Understanding of cybersecurity requirements for connected medical devices.
• Technical Oversight
  • Ensure adherence to applicable standards such as IEC 60601, ISO 14708, ISO 14971, IEC 62304, and other related AIMD requirements.
  • Provide input to integration planning and test execution across electrical, mechanical, and software.
• Project & Process Management
  • Support the product lifecycle from concept through verification, validation, transfer to manufacturing, and post-market support.
  • Ensure rigorous risk management practices, including hazard analysis and FMEA, are applied to all designs.
• Establish and advocate for best practices and continuous improvement to mature Systems Engineering knowledge and processes.
• Collaborate with all functions within R&D, and across the organization to ensure the role of Systems Engineering is understood.
• 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.
• Other job duties as assigned.

• Education & Experience
  • Bachelor’s in Electrical Engineering, Software Engineering, or related field. Master’s degree in related field is preferred.
  • 7+ years of engineering experience.
  • Active Implantable medical device system experience.
  • Experience or knowledge of software, analog and digital systems.
  • Systems level design experience with active implantable medical devices, including those that use external programmers.

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…