Manager, Systems and Software Engineering

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Location:

Minneapolis, MN, US

Job Family:
Research & Development

Country/Region:
United States

Job Function Summary
The Manager, Systems and Software Engineering will lead a multidisciplinary team of software and electrical engineers in the design, development, and maintenance of active implantable medical devices (AIMDs).

Reporting to the Director, Product Development, Implantables, this role is accountable for ensuring that designs meet clinical performance targets, safety requirements, and international regulatory standards, while driving innovation and technical excellence.

Major Areas of Accountability

Leadership & Management

• Lead, mentor, and develop a cross-functional engineering team covering embedded software, firmware, and associated systems.
• Allocate resources, set priorities, and manage workload to meet project timelines and deliverables.
• Foster a culture of innovation, technical rigor, and quality compliance.
• Strong people management skills with the ability to inspire, coach, and develop talent.
• Excellent cross-functional collaboration and communication abilities.
• Strategic thinking with hands-on problem-solving skills.

Technical Oversight

• Guide the architecture, design, and integration of embedded software for AIMDs.
• Ensure adherence to applicable standards such as IEC 60601, ISO 14708, ISO 14971, IEC 62304, and related AIMD requirements.
• Collaborate with all functions within R&D, and across the organization, inlcuding clinical experts to ensure holistic product performance.

Project & Process Management

• Support product lifecycle management 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.
• Champion design control processes in accordance with FDA 21 CFR Part 820 and EU MDR requirements.
• Coordinate with Quality, Regulatory, and Clinical teams to ensure regulatory submissions are supported with robust technical documentation.
• Drive adoption of best practices in model-based design, design for manufacturability, and design for reliability.
• Evaluate and integrate emerging technologies to enhance device capabilities and patient outcomes.
• Identify opportunities to streamline development while maintaining compliance
• 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 Software Engineering, or related field. Master’s degree in related field is preferred.
• 8+ years of engineering experience.
• 3+ years in a leadership or managerial role.
• Proven track record developing safety-critical, implantable, or Class III medical devices.
• Strong knowledge of embedded systems and safety-critical software.

Technical Skills

• Expertise or high level of understanding in C, C++, Kotlin, Java, Python.
• Familiarity with regulatory standards and risk management for medical devices.
• Understanding of cybersecurity requirements for connected medical devices.

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…