Software Medical Device Engineer

Responsibilities

• Plan and execute migration of requirements and related data from legacy tools (e.g., DOORS, Jama, Excel, Jira) into new platforms, ensuring data integrity, traceability, and compliance.
• Administer, configure, and maintain enterprise requirements management tools, including hierarchies, templates, workflows, versioning, and baselining in alignment with the quality system.
• Develop and maintain a requirements management plan in collaboration with cross-functional teams, defining the overall requirements structure and links to associated design control documents.
• Create and maintain standardized requirements templates, traceability frameworks, and governance models based on quality and regulatory requirements.
• Maintain the requirements database, develop scripts or automation as needed, and support integrations or add-in tools to improve usability and efficiency.
• Provide training, documentation, and ongoing support to engineers, serving as the primary functional expert for requirements tools and best practices.

Requirements

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or a related discipline for requirements management.
• A minimum of 5 years with hands-on experience administering or configuring enterprise requirements management tools to support regulated development environments (e.g., Codebeamer, DOORS, Jama, or comparable platforms).
• Ability to quickly learn and adopt new tools is expected.

Preferred Qualifications

• Experience acting as a tool administrator, configuration owner, or advanced power user in a regulated development environment.
• Experience defining or scaling requirements management frameworks for large or multi-team programs.
• Familiarity with medical device development (FDA 21 CFR Part 820) with the ability to configure tools to support compliant workflows.
• Experience supporting software-driven, connected, or mobile medical devices.
• Experience with different requirements management or lifecycle tools is valued; strong foundational understanding of requirements structures and traceability is more important than experience with a specific platform.