Senior Design Assurance Engineer, Software

The Interventional Urology Sr. Design Assurance Engineer, software is responsible for supporting new product development and commercial products.  The position is responsible for ensuring all products are structured correctly per standard requirements, quality systems and global regulations.  This role will support software project initiatives for active implantable devices and will be a key member of our product development teams.

Major Areas of Accountability

• Serve as a Design Assurance partner on New Product Development (NPD) projects, participating in and leading phase, design, and test readiness reviews.
• Partner with R&D to define, review, and approve software and system design inputs, outputs, and traceability in compliance with design controls.
• Ensure applicable software, electrical, and system standards are correctly applied; support development and validation of software-related test methods.
• Lead and support software risk management activities, including Hazard Analysis, Software FMEA, DFMEA, and usability risk assessments.
• Support planning and execution of software verification and validation (V&V), including protocol development, test execution oversight, issue investigation, data analysis, and reporting.
• Drive continuous improvement of Design Assurance processes, SOPs, and quality deliverables to improve efficiency and compliance.
• Act as Design Assurance support for regulatory submissions, responses, and audits (internal and external).
• Support design and process changes for commercialized products, including change impact assessment and documentation updates.
• Support design transfer from development to manufacturing, including supplier and contract manufacturer interactions.
• Provide statistical and analytical support for software test methods, validation strategies, and sample size rationale.
• 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 duties as assigned

Basic Qualifications

• Bachelor’s Degree in Computer Science, Computer Engineering, Electrical Engineering, or related field
• 5+ years related experience in this field – Medical device experience preferred
• Active Implantable medical device system experience
• Experience with regulatory standards including IEC 62304, 60601, FDA 510(k), ISO 14971, 13485
• Knowledge of cybersecurity best practices and standards
• Good written and verbal communication
• Ability to consistently work, manage and lead with ethical integrity
• Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Promise
  

   

  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 $105,868  - $158,802. 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.

Visit us on Coloplast.com.

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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.

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