Senior Manager, Software Requirements Engineering

$163,564 - $256,000/Yr

BD - Franklin Lakes, NJ

Full-time - Senior

Franklin Lakes, NJ

Miscellaneous Manufacturing

About the position

The Senior Manager, Software Requirements Engineering at BD is responsible for leading and mentoring a team of software requirements engineers. This role involves providing technical documentation for the design, implementation, and testing of software medical devices, ensuring compliance with regulatory standards, and guiding cross-functional project teams in product engineering projects. The position emphasizes the creation of clear product requirements and the definition of process improvement initiatives, all while supporting audits and corrective actions in a fully remote environment.

Responsibilities

• Provide leadership and mentoring to a team of software requirements engineers.
• Create technical documentation for the design, implementation, and testing of software medical devices.
• Document and repair errors related to the software development lifecycle.
• Collaborate with cross-functional project teams to complete Product Engineering projects with minimal guidance.
• Articulate design deliverables for applicable regulatory standards, ensuring maintainability and accuracy.
• Create clear and accurate product requirements and guide the scope of design outputs.
• Partner with Software Engineering, Product Ownership, Systems Engineering, Risk Management, and Quality to create deliverables.
• Define, contribute to, and lead process improvement initiatives.
• Support internal and external audits and any corrective actions.

Requirements

• Master's degree in Engineering, Biomedical Sciences, Biology, Management, Technology, or related field and eight years of experience in the job offered or related occupation.
• In lieu of a Master's degree, a Bachelor's degree in the same fields with ten years of experience is acceptable.
• Demonstrated experience in collaborative enterprise environments building cloud and on-prem based software products.
• Experience designing controls processes necessary for product development.
• Proficient in writing and updating System and Software requirements and generating required documentation.
• Experience in product development and deliverables for Software products.
• Knowledge in Business Analysis, Product Management, and Risk Management for Software Products.
• Ability to research diverse data sources and formulate specific questions and hypotheses for projects.
• Familiarity with software-specific FDA and international standards such as ISO 13485, ISO 14971, IEC 62304, and FDA premarket guidance on Software.
• Experience with Phase-Gated Product Development and Agile processes.

Benefits

• Competitive salary range of $163,564.00 - $256,000.00/year.
• Remote work flexibility.
• Opportunities for professional growth and development.