Senior Manager, Software Requirements Engineering

Summary of duties: Providing leadership and mentoring of a team of software requirements engineers and other functional areas as required. Provide technical documentation for the design, implementation and testing of the software medical devices. Document and repair errors related to software development lifecycle. Work with cross-functional project teams to complete Product Engineering projects with minimal guidance. Guide the articulation of design deliverables for the applicable regulatory governing standards; artifact scope, purpose, perspective, granularity, and overall level of abstraction to ensure the ongoing maintainability and accuracy of each deliverable. Create clear, accurate, and well-thought-out product requirements. Guide the articulation and scope of design outputs, including the distribution of concerns between design input versus output. Partner with Software Engineering, Product Ownership, Systems Engineering, Risk Management, and Quality in the creation of deliverables. Define, contribute to, and lead process improvement initiatives. Support internal audits, external audits, and any corrective actions. 100% telecommuting role. Reports to company headquarters in Franklin Lakes, NJ.Qualifications: Master's Degree in Engineering (any), Biomedical Sciences, Biology, Management, Technology or related field of study and 10 (ten) years of experience in the job offered or related occupation in which the required experience was gained. The employer will also accept a Bachelor's degree in Engineering (any), Biomedical Sciences, Biology, Management, Technology or related field of study and ten (10) years of work experience in the job offered or related occupation in which the required experience was gained. Applicants must have demonstrated experience in the following: Working in collaborative, enterprise environments building cloud and on-prem based software products; Designing controls process necessary for product development; Writing and updating System and Software requirements and generating required documentation; Product development and deliverables for Software products; Business Analysis, Product Management and Risk Management for Software Products; Researching diverse sources of data and formulating specific questions and hypotheses for various projects; Software specific FDA and other international standards such as ISO 13485, ISO 14971, IEC 62304 and FDA premarket guidance on Software; and Phase-Gated Product Development as well as Agile processes supporting complex Software product development.To apply, mail resume to Becton, Dickinson and Company, Attn: BDHR - DT, 3750 Torrey View Ct, San Diego, CA 92130, OR submit a resume to OR submit a resume to CAREER SITE_USA. Must reference Job Title: Senior Manager, Software Requirements Engineering & Job Code: R-501380. EOE.

Created: 2024-10-19