Staff Engineer, Systems Engineer

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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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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 Med Tech 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.

• Reporting to a more senior level engineering staff/manager or higher, this associate will bring engineering skills. The associate will support/lead R&D activities. These activities include but not limited to overall product development and responsibility of R&D deliverables.
• The associate may also be responsible to deliver, with high technical competence and capability, several aspects of product requirements, design, analysis, verification, validation, and transfer of products that meet both customer and business needs. Responsibility may span from concept and technology development, product development, to product lifecycle management for on-time and on-budget delivery. The responsibilities may include leading projects or teams in the US, Europe and Asia as well as develop and acquire talent with new abilities as needed.
• Each job level is delineated by the educational level, years of experience, and capabilities. It also defines the level of responsibilities such as supporting or leading the task, project, or program.

Roles & Specific Responsibilities

• Lead/serve as a core team member representing R&D function in a multi-functional team environment to release design control work to support the development, improvement, and commercialization of new and improved products.
• Build, develop, own, and implement technical strategies on projects.
• Manage/Coach the extended team for duration of project and effectively allocate work within the project.
• Manage stakeholders within projects to ensure technical strategies, risks, and decisions are understood and aligned.
• Serve as SME in product development and design change control process in accordance with 21 CFR Part 820 & ISO 13485.
• Support regulatory submissions as technical lead.
• Own project deliverables from Design Inputs to Design Transfer, leveraging expertise from extended team members.
• Facilitate and own technical decisions and recommendations.

• B.S. degree or higher in engineering or related fields with the following years of experience
• B.S. degree with a minimum of 5+ years of experience, or Advanced Degree w/ 2-3 years of experience.
• Proven experience in product development with experience developing and releasing products to market or releasing large sustaining projects to market.
• Expertise with design controls (21 CFR Part 820, ISO 13485) & risk management (ISO 14971).
• Working experience in medical device regulations and submission processes.
• Excellent communication of technical and complex problems to all levels of organization.
• Demonstrated ability to lead teams and influence others.
• Ability to evaluate, compare, and make trade‑off decisions.
• Ability to manage complex data.

• Exceptional team leadership skills, and ability to motivate and inspire others.
• Foundational understanding in one or more of the following areas:

• Design for Six Sigma (DFSS)
• MBSE/SysML & Requirements Management.
• Statistical tools, methodologies and…