Manager, Systems and Software Engineering

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

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  Leadership & Management

  
  

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  Lead, mentor, and develop a cross-functional engineering team covering embedded software, firmware, and associated systems.

  
  

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  Allocate resources, set priorities, and manageworkloadto meet project timelines and deliverables.

  
  

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  Foster a culture of innovation, technical rigor, and quality compliance.

  
  

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  Strongpeoplemanagement skills with the ability to inspire, coach, and develop talent.

  
  

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  Excellent cross-functional collaboration and communication abilities.

  
  

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  Strategic thinking with hands-on problem-solving skills.

  
  

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  Technical Oversight

  
  

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  Guidethe architecture, design, and integration of embedded software for AIMDs.

  
  

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  Ensure adherence to applicable standards such as IEC 60601, ISO 14708, ISO 14971, IEC 62304, and related AIMD requirements.

  
  

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  Collaborate with all functions within R&D, and across the organization,inlcudingclinicalexpertsto ensure holistic product performance.

  
  

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  Project & Process Management

  
  

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  Support product lifecycle management from concept through verification, validation, transfer to manufacturing, and post-market support.

  
  

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  Ensure rigorous risk management practices, including hazard analysis and FMEA, are applied to all designs.

  
  

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  Champion design control processesin accordance withFDA 21 CFR Part 820 and EU MDR requirements.

  
  

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  Coordinate with Quality, Regulatory, and Clinical teams to ensure regulatory submissions are supported with robust technical documentation.

  
  

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  Innovation & Continuous Improvement

  
  

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  Drive adoption of best practices in model-based design, design for manufacturability, and design for reliability.

  
  

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  Evaluate and integrate emerging technologies to enhance device capabilities and patient outcomes.

  
  

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  Identifyopportunities to streamline development whilemaintainingcompliance

  
  

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  Coloplast employeesare required toconduct business to the highest ethical and professional standards;comply withapplicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

  
  

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  Other job duties as assigned

  
  

Basic Qualifications

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  Education & Experience

  
  

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  Bachelor's in Software Engineering, or related field.Master'sdegree in relatedfieldis preferred.

  
  

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  8+ years of engineering experience.

  
  

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  3+ years in a leadership or managerial role.

  
  

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  Proventrack recorddeveloping safety-critical, implantable, or Class III medical devices.

  
  

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  Strong knowledge of embedded systems and safety-critical software.

  
  

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  Technical Skills

  
  

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  Expertiseorhigh levelof understanding in C, C++, Kotlin, Java, Python.

  
  

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  Familiarity with regulatory standards and risk management for medical devices.

  
  

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  Understanding ofcybersecurity 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:

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  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-birthingparents.

  
  

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  Financial Security:A competitive 401(k) plan withcompanymatchthat vestimmediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.

  
  

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  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.

  
  

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  Professional Development:Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.

  
  

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  Recognition and Rewards:Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, andspecial events.

  
  

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  Community and Culture:A supportive work environment where everyone feelsvalued, andhas 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.

  
  

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  Competitive Compensation: The compensation range for this position is $125,000 - $185,000.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 receiveadditionalcompensation in the form of bonuses and/or incentives.