Job Description Summary

The Staff Systems Engineer I is a key role in the Beads R&D Reagents team, and will act as the liaison between new & current bead-related products and the flow cytometry instruments that these products support. This role is expected to use judgment based on a combination of experience and knowledge from backgrounds in biology, flow cytometry, and instrument systems to both help develop new, and to help sustain existing bead products in BD Biosciences.

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 Summary:

The Staff Systems Engineer I is a key role in the Beads R&D Reagents team, and will act as the liaison between new & current bead-related products and the flow cytometry instruments that these products support.  This role is expected to use judgment based on a combination of experience and knowledge from backgrounds in biology, flow cytometry, and instrument systems to both help develop new, and to help sustain existing bead products in BD Biosciences.  The Staff Systems Engineer I will additionally be expected to leverage scientific and statistical methods to determine root cause of complex issue, while guiding the team and products successfully through company Quality Management Systems (QMS).

The Staff Systems Engineer I works closely between Reagents R&D, Beads Manufacturing, Quality Control, Regulatory, and the Instrument Systems Engineering team to lead and sustain the complex connections between life science reagent products and instruments. This role understands customer needs and workflows, systems architecture and analysis, and how the different sub-systems will fit and interact to meet the desired customer function and experience.

Job Responsibilities:

• Lead bead product-related Systems Engineering activities and deliverables, including Validation and Verification activities.

• Partner with design teams and QMS to meet ongoing customer needs through design collaboration, prototype integration, characterization and optimization.

• Act as an intermediary between R&D, Manufacturing, QC and Regulatory to document and validate process changes.

• Lead and engage cross-functionally in technical troubleshooting

• Designing new or refining existing manufacturing or QC processes using lean and six sigma methodologies

• Lead root cause investigations, corrective actions, and verification of effectiveness activities.

• Guide, review and develop formal and informal test protocols.

• Be primary stakeholder in Design and Technical Reviews to practice sound decision making across the program

• Provide technical support to a wide range of problems pertaining to specific programs and projects.

• Work effectively and collaboratively in a cross functional team and with external partners to identify, communicate, and mitigate program needs at each product lifecycle.

• Lead or actively participate in design of experiment, action item implementation, and troubleshooting activities

Education and Experience:

• Minimum of a Bachelor’s degree in Biology, Engineering, or related discipline, e.g. Biomedical, Electrical, or Mechanical. Master’s degree or PhD preferred.

• Minimum of 9 years of experience in systems engineering, product development, or product design.

• Experience in one or more areas related to flow cytometry or cell analysis such as signal processing, embedded systems, electronics, software, fluidics, optics, and/or assay reagents strongly preferred.

• Experience in lab automation, Laboratory Information Systems (LIS) and 21 CFR Part 11 Compliance is highly desired.

• Experience in design control in a regulated environment.

• Familiarity with external contract design and manufacturing facilities.

• Familiarity with regulations and compliance testing is desired

Knowledge and Skills:

• Previous Design Control Experience in a regu