Sr Manager, Quality Engineering - Software

Becton Dickinson Medical Devices•San Diego, CA

20h•Onsite

About The Position

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health ™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Description Summary: Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security. Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively. Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.). Quality support of US and OUS sites. Manage quality metrics and present them in management reviews. Responsible to assigned or being the prime quality representative for design control projects – new product development as well as sustaining efforts. Review and/or approval of design history file documentation in support of design controls. Manage all quality aspects of the design control process: quality planning; requirements generation and traceability, code reviews, integration testing, verification and validation planning and execution; risk management; regulatory, compliance and product security support. Lead the defect tracking process and management of issues prior to release and any issues that may present from the post-market surveillance teams. Quality representative in risk management activities including approval of risk management reports and risk analyses. Work closely with Program Management to ensure design deliverables are met and can be released to limited commercial and/or general release. Work together with SW Quality Engineers and SW Quality Managers to ensure effective verification of design specifications and/or requirements. Review effectiveness of assessments of DHFs and Change Orders and/or Electronic Release Authorizations for new releases or design enhancements. Active participant in the development of product requirement, product system hazard analysis and design reviews. Work closely with Product Management and UX teams to ensure effective validation of user needs. Ensure product technical files and Design History Files are complete, traceable and auditable. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Provide decisions, recommendations, and results to further the achievement of goals critical to organizational objectives. Identify areas requiring quality improvement and initiate and follows through plans of action (Quality Plans) necessary for implementation. Responsible to provide Quality support in 510k or International submissions as warranted. Successful completion of major programs/initiatives and may function in a project leadership role.

Requirements

Master’s degree in Engineering (any), Life Sciences or related field of study and eight (8) years of experience in the job offered or related occupation in which the required experience was gained.
In lieu of a Master’s degree in Engineering (any), Life Sciences or related field of study and eight (8) years of experience, the employer will also accept a Bachelor’s degree in Engineering (any), Engineering (any), Life Sciences or related field of study and ten (10) years of experience in the job offered or related occupation in which the required experience was gained.
Must have demonstrated experience with: Regulatory requirements (cGMP, FDA or ISO); Design controls and risk management methodologies; Agile methodologies and software development life cycle; Quality principles (ISO 13485, IEC 62304, IEC 14971 or 21 CFR) to the R&D environment; cybersecurity design considerations; and software development life cycle and test methodology.

Responsibilities

Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security.
Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively.
Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).
Quality support of US and OUS sites.
Manage quality metrics and present them in management reviews.
Responsible to assigned or being the prime quality representative for design control projects – new product development as well as sustaining efforts.
Review and/or approval of design history file documentation in support of design controls.
Manage all quality aspects of the design control process: quality planning; requirements generation and traceability, code reviews, integration testing, verification and validation planning and execution; risk management; regulatory, compliance and product security support.
Lead the defect tracking process and management of issues prior to release and any issues that may present from the post-market surveillance teams.
Quality representative in risk management activities including approval of risk management reports and risk analyses.
Work closely with Program Management to ensure design deliverables are met and can be released to limited commercial and/or general release.
Work together with SW Quality Engineers and SW Quality Managers to ensure effective verification of design specifications and/or requirements.
Review effectiveness of assessments of DHFs and Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.
Active participant in the development of product requirement, product system hazard analysis and design reviews.
Work closely with Product Management and UX teams to ensure effective validation of user needs.
Ensure product technical files and Design History Files are complete, traceable and auditable.
Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
Provide decisions, recommendations, and results to further the achievement of goals critical to organizational objectives.
Identify areas requiring quality improvement and initiate and follows through plans of action (Quality Plans) necessary for implementation.
Responsible to provide Quality support in 510k or International submissions as warranted.
Successful completion of major programs/initiatives and may function in a project leadership role.