Manager, Systems and Software Engineering

Coloplast A/S-posted 3 months ago
$105,071 - $157,606/Yr
Full-time • Manager
Minneapolis, MN
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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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Comprehensive medical, dental, and vision insurance plans.
  • Access to company sponsored wellness programs and mental health resources.
  • Paid leave of absence for qualifying events and generous paid parental leave.
  • A competitive 401(k) plan with company match that vest immediately.
  • Financial planning services to help secure your future.
  • Generous paid time off, flexible work hours, and flexible work arrangement options.
  • Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
  • Recognition programs to celebrate achievements and contributions.
  • A supportive work environment with team-building activities and volunteer opportunities.
  • Sustainability strategy that outlines ambitions for sustainable operations.
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