Senior R&D Engineer, Software

The Interventional Urology Senior R&D Engineer, Software, is responsible for leading, defining, and evaluating new product development and existing programs to ensure all products are structured correctly per standard requirements, quality systems and global regulations.  This role will support all software project initiatives for active implantable devices and will be a key member of our product development team.

Major Areas of Accountability

• Primary lead for developing and testing medical device software (C, C++, Kotlin, Java, Python)
• Document design input requirements leveraging best practices, including object-oriented design methods
• Define, capture, triage and manage software bugs
• Partition functional requirements between the system and subsystem components
• Participate in verification and validation activities to determine that requirements are implemented as specified and satisfy the customer’s intent
• Document software requirements by writing documents, reports, memos, change requests.  Methods used are determined by approved procedures and standards
• Mentor and guide other members of the technical team as it relates to the overall system features, requirements and issue resolution
• Collaborate and communicate effectively with external vendors to align project requirements, timelines and deliverables.
• Identify and implement improvements to Standard Operating Procedures
• Thorough understanding of software risk management processes and deliverables
• Create and maintain virtual models of software components to interact with each other to utilize during development, simulation, and testing
• 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

• 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.