Software Medical Device Engineer

Location: Pleasanton CA .

The contract is for 1 year.

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.

REQUIRED QUALIFICATIONS:
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.
Hands on experience with requirements migration from legacy tools.
Strong understanding of medical device product development and design control principles.
Excellent verbal and written communication skills with the ability to train and support engineers at all levels.
Ability to work effectively in a collaborative environment.

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.