R&D Engineer, Software

The Interventional Urology Software Engineer is responsible for design, development and verification of software that powers life changing, safety-critical medical devices. 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 developer 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.

* Design, develop and maintain embedded firmware for microcontroller-based medical devices under the guidance of senior engineers.

* Contribute to development tools, workflows and engineering processes to support software integrity and reliability.

* Collaborate with hardware, systems and quality engineering teams to support system integration and overall product development.

* Participate in software design reviews, code reviews and risk assessment to ensure high-quality deliverables.

* Develop and execute unit and integration tests to support robust software performance.

* Support verification and validation activities, including documentation, traceability and regulatory compliance.

* Troubleshoot and debug firmware issues, contributing to root cause analysis and resolution.

* Apply software development best practices and continuously build technical knowledge in embedded systems.

* 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.

* 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

* Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Med Tech Code of Conduct, and company policies.

* Other duties as assigned

Basic Qualifications

* Bachelor's degree or master's degree in computer science, Computer Engineering, Electrical Engineering, or related field

* 2+ years related experience in this field - Medical device experience preferred

* Proficiency in C and/or C++ within embedded or resource-constrained systems.

* Foundational understanding of software development lifecycle practices.

* Experience with debugging and testing embedded systems.

* 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

Required Knowledge,

Skills and Abilities

* Exposure with regulatory standards including IEC 62304 or other regulatory software lifecycle processes.

* Knowledge of cybersecurity best practices and standards

* Exposure to wireless communication protocols such as BLE or Wi-Fi

* Familiarity with Agile or Scrum environments and tools such as Jira, Azure Dev Ops

* Familiarity with bootloaders, over-the-air updates and secure firmware concepts.

* Experience with scripting languages such as Python for basic automation

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…