Principal R&D Engineer, Systems

Coloplast; Minneapolis, Northern (MN, KY); On-site; USD 117,000 - 175,000; Full time

Benefits offered by this job

Health and Wellness benefits

401(k) with company match

Generous paid time off

Flexible work hours

Tuition reimbursement

Bonuses and incentives

Job summary

Coloplast is seeking an Interventional Urology Principal Systems Engineer to lead product development using a systems approach, ensuring customer requirements, standards, and global regulations are met for implantable devices.

You will drive architecture, requirements tracing, risk management, and cross-functional collaboration while supporting the lifecycle from concept to post-market. Strong emphasis on cybersecurity and compliance with AIMD standards is expected.

Qualifications

• Bachelor's degree in Electrical Engineering, Software Engineering, or related field.
• 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.

Responsibilities

• Drive the architecture, system design, system boundaries and all interfaces.
• Lead requirements hierarchy strategy with performance metrics.
• Understand requirement leveling and tracing.
• Foster innovation, technical rigor, and quality compliance.
• Cross-functional collaboration and communication abilities.
• Provide guidance, coaching, and training to others in the job area.
• Demonstrate strategic thinking and problem-solving skills.
• Understand cybersecurity requirements for connected medical devices.
• Ensure adherence to standards such as IEC 60601, ISO 14708, ISO 14971, IEC 62304.
• Input to integration planning and test execution across electrical, mechanical, and software.
• Support the product lifecycle from concept through verification, validation, transfer to manufacturing, and post-market support.
• Maintain robust risk management practices including hazard analysis and FMEA.
• Establish best practices and continuous improvement for Systems Engineering knowledge and processes.
• Collaborate with R&D and other functions to promote the Systems Engineering role.

Skills

Systems engineering

Electrical engineering

Software engineering

Requirements tracing

Cross-functional collaboration

Cybersecurity for medical devices

Education

Bachelor's degree in Electrical or Software Engineering

Master's degree preferred

Tools

IEC 60601

ISO 14708/ISO 14971

IEC 62304

Job description

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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.

Major Areas of Accountability

• 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.

Basic Qualifications

• 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 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.

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.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark