Staff Systems Engineer

Job Description Summary

Job Description

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.

A Systems Engineer in this role is responsible for using their broad technical expertise, leadership skills, and product development knowledge to provide Systems leadership through different phases of product life cycle. This Systems Engineer is accountable for developing and driving sound strategies for regulatory submissions and registrations for sophisticated new product development projects. This position works with multiple projects and functional teams with limited oversight, provides instruction, mentorship, and regulatory interpretations to functional staff and Core Teams to achieve rapid worldwide clearance/approval/registrations of BD Dispensing Products. In addition, translates voice of customer, partner and regulatory needs into system and product requirements, identifies potential hazards and assesses requirements to ensure that the product meets the user/business needs, develops design and process specifications for new hardware and software products, aids in product verification and validation, and provides support in sustaining activities. The expectation for a Staff Systems Engineer is that they regularly serve on smaller project core teams, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function. As such they are expected to help identify tasks/resources to ensure that critical project landmarks are met and systems integration activities are identified and fulfilled.

Essential Functions:

Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)

Provide multi-functional support for regulatory submissions and compliance, including approval of product labeling, promotional, and advertising materials; review of clinical and human factors protocols; regulatory leadership on business continuity projects and writing/updating standard operating procedures, work instructions, and policies.

Identify and communicate appropriately quantified risks and mitigations associated with regulatory strategies to multi-functional partners

Provide timely review and approval of product labeling and marketing claims for regulatory compliance

Working knowledge of product development lifecycle

Leads system/product-level feasibility and risks assessments

Facilitates multi-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues

Finds opportunities and drives continuous improvement efforts

Applies DFSS standard methodologies on all projects.

Required Qualifications:

Must have a Bachelor’s degree in Science or Engineering or equivalent degree and work experience

Five (5) years experience with medical devices in other functions (e.g., QA, R&D, etc.) with demonstrated support of regulatory submission development and approval from the FDA and other global regulatory agencies or combination of work experience and advanced degrees

Strong understanding of Basic Safety and EMC Standardse.g. 60601-1, 61010-1, 60601-1-2

Good understanding of ISO 15223-1 and ISO 20417

Quality Management System in SAP

Team Foundation Server

Skills/Attributes:

Ability to work independently and as a member of a team.

Ability to lead multi-discipline engineering teams.

A strong technical background within Systems Engineering, medical device development, or similar

Experience with Systems Engineering and requirements management.

Familiar with systems integration and testing, system architectural planning and design, Reliability Engineering, Project Management, and Failure Modes Effects Analysis.

DFSS knowledge and experience or statistical test design and analysis knowledge or Critical Parameter Management.

Knowledge ofglobal medical device regulations

Performed regulatory compliance assessments for US and Outside US

Experience with label compliance for US and Outside US

Excellent communication skills with the following departments: interdepartmental (with fellow engineers), cross-functional (with Marketing, Clinical Representatives, Software Engineers, Test Engineers, and Quality Engineers)

Identified opportunities for continuous improvement projects/efforts.

Experience working within an agile environment a plus.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit  https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA CA – San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/benefits) .

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$121,100.00 – $199,800.00 USD Annual

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.