Senior Manager, Software Requirements Engineering

BD - Franklin Lakes, NJ

Full-time - Senior

Remote - Franklin Lakes, NJ

Miscellaneous Manufacturing

About the position

The Senior Manager, Software Requirements Engineering at Becton, Dickinson and Company is responsible for leading a team of software requirements engineers and collaborating with cross-functional project teams to ensure the successful design, implementation, and testing of software for medical devices. This role involves creating and maintaining technical documentation, guiding design deliverables, and driving process improvement initiatives while ensuring compliance with regulatory standards. The position is fully remote, allowing for flexibility in work location.

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.
• Guide the articulation of design deliverables according to regulatory standards.
• Create clear and accurate product requirements.
• Define and lead process improvement initiatives.
• Support internal and external audits and corrective actions.

Requirements

• Master's Degree in Engineering, Biomedical Sciences, Biology, Management, Technology, or a related field and 10 years of experience in the job offered or a related occupation.
• Alternatively, a Bachelor's degree in the same fields with 10 years of relevant work experience.
• Demonstrated experience in collaborative enterprise environments building cloud and on-prem based software products.
• Experience in 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 supporting complex Software product development.