Sr. Engineer; Hybrid - Brea, CA

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Job Description Summary

Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems. Demonstrates working knowledge of product design and development. Demonstrates working knowledge of design control process. Tests, analyzes and solves technical problems with moderate guidance.

Applies basic statistical techniques and utilizes design of experiments with moderate guidance. Translates customer needs into design inputs; verifies design output meets design input. Works with moderate guidance. Translates requirements into basic designs under the guidance of others. Creates and tests prototypes. Maps the intellectual property landscape. Has developed knowledge and skills in own job family; still acquiring / expanding fundamental knowledge and higher-level skills.

Applies knowledge and skills to a variety of standard activities. Works with moderate guidance in own area of knowledge.

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 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.

While maintaining a Customer Focus, responsibilities include (but are not limited to):

• Strategy development and Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation, and Design Transfer activities.

• Demonstrates proficiency in creating technical drawings, developing design verification strategies, conducting functional device testing, performing testing by analysis, technical writing (protocols, reports, work instructions), and applying engineering principles for design and analysis, including statistical analysis and sample plan development.
• Identifies external technologies and their critical strengths/weaknesses, nurtures Invention Disclosure Records (IDRs) from early stages, and contributes to the organization's intellectual property portfolio through creative problem-solving and innovative approaches.
• Actively participates in external activities that enhance BD's brand recognition, including writing technical papers and generating intellectual property (IP), while staying current with industry developments and expanding professional knowledge.
• Demonstrates accountability for timely achievement of goals, assesses project needs, mitigates risks, supports Business Development Goals (BDGs), represents BD on standards committees, and communicates effectively with cross-functional partners while resolving team conflicts.
• Exhibits strong interpersonal influence and persuasion skills with situational awareness, promotes an inclusive work environment that leverages diversity, demonstrates decisiveness despite ambiguity, and autonomously drives projects and deliverables with minimal supervision.

• Bachelor's Degree in Mechanical or Biomedical Engineering with 6+ years of experience in medical device or other regulated industry, OR an Advanced Degree in Mechanical or Biomedical Engineering.
• Demonstrated track record of technical problem solving, effective product development, proficiency in solid mechanics/mechanics of materials, and statistical methods/tools.
• Design controls expertise for medical or regulated industry, with knowledge of regulatory standards including FDA QSR 21 CFR 820, ISO 13845, ISO
  14971, ISO…