BD is looking to ensure software quality across STS and Incada, manage software quality engineering teams, and ensure compliance with regulatory standards and internal quality systems.
Requirements
Expert knowledge of software development lifecycle and test methodologies.
Strong understanding of design controls, risk management, and product security.
Familiarity with regulatory standards including ISO 13485, IEC 62304, and 21 CFR.
Experience in Agile/SAFe methodologies is preferred
Experience in Cloud/SaaS software product development is preferred
Responsibilities
Leading the development, establishment and maintenance of Quality Assurance and Engineering programs in the STS team.
Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and development.
Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security.
Align software validation practices across BD.
Manage quality metrics and present them in management reviews.
Provide Design and Development leadership during FDA and Notified body site inspections.
Interface with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors
Other
15+ years of experience in software design and development within Medical Device regulated industry.
Experience managing software quality engineering teams and leading complex software projects.
ASQ certifications (CQA, CQE, CSQE, CMQ) are a plus.
Excellent leadership, project management, and cross-functional collaboration skills.
Ability to influence without direct authority and manage organizational change.
