Job Description Summary

Title: Staff Systems Engineer

Location: San Diego, CA, Hybrid

Department: R&D, Released Product Management (RPM)

About BD:

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. 

Job Description:

We are seeking a highly skilled and experienced Staff Systems Engineer to join our R&D Released Product Management (RPM) team, which supports Alaris infusion products. The ideal candidate will have a strong background in medical device engineering and a deep understanding of industry standards and methodologies. They will wear multiple hats and work with core team members across engineering and project disciplines.

Key Responsibilities:

• Provide technical leadership over multiple projects simultaneously.

• Support product design changes and ensure they meet regulatory and quality standards.

• Coordinate activities related to product changes with multiple cross-functional teams, including operations, quality, regulatory, and others.

• Evaluate risks associated with product changes and provide mitigation strategies.

• Provide input on reliability, verification, and validation testing.

• Ensure compliance with ISO 13485, 14971, CFR21, CSA and other relevant regulations and standards.

• Utilize statistical testing methods and design for manufacturing (DFM) and design for six sigma (DFSS) methodologies.

• Collaborate with cross-functional teams to ensure successful product updates and solve complex problems under time sensitive deadlines

• Conduct root cause analysis and implement corrective actions for product issues.

• Maintain thorough documentation of design changes, testing results, and risk assessments.

• Interact with hardware suppliers to ensure design for manufacturability, testability and overall reliability

Qualifications:

• Bachelor's, master's or PhD degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field.

• Minimum 10 years of related experience.

• Track record of working successfully in a rapidly changing environment with high levels of uncertainty

• Strong understanding of ISO 13485, 14971, and other relevant standards.

• Knowledge of regulatory requirements for medical devices

• Experience with risk management and failure mode and effects analysis (FMEA).

• Experience with statistical testing methods.

• Excellent problem-solving skills and the ability to work in a fast-paced environment.

• Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.

• Ability to manage multiple projects and priorities simultaneously.

• Proficiency in using engineering tools and software for design and analysis.

Preferred Qualifications:

• Experience with Alaris infusion products or similar medical devices.

• Certification and experience in design for manufacturing (DFM), design for six sigma (DFSS) methodologies.

• Critical components and critical parameters management experience.

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