Coloplast · 2 days ago
Manager, Systems and Software Engineering
Minneapolis, MN
Full-time
Onsite
Senior Level, Lead/Staff
$105K/yr - $158K/yr
8+ years expColoplast is a leading medical device company developing and marketing products for intimate healthcare needs. The Manager, Systems and Software Engineering will lead a multidisciplinary team in the design and maintenance of active implantable medical devices, ensuring compliance with clinical performance and regulatory standards.
Health CareManufacturingMedical Device
Responsibilities
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
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, including clinical experts to ensure holistic product performance
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
Other job duties as assigned
Qualification
Required
Bachelor's in Software Engineering, or related field
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
Preferred
Master's degree in related field
Benefits
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
Access to company sponsored wellness programs and mental health resources.
Paid leave of absence for qualifying events.
Generous paid parental leave for both birthing and non-birthing parents.
A competitive 401(k) plan with company match that vest immediately.
Financial planning services to help you secure your future.
Corporate discount programs for goods and services.
Generous paid time off.
Flexible work hours.
Flexible work arrangement options to help you balance your personal and professional life may be available.
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
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.
Company
Coloplast
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.34B2023-08-29Post Ipo Equity· $1.34B
2000-02-04IPO
Leadership Team
Lars Rasmussen
Chairman of the Board of Directors
Recent News
Essential Business
2025-12-20
2025-12-18
2025-12-05
Company data provided by crunchbase