Senior Supplier Development Engineer

Usa Ca - Irvine Laguna Canyonsenior

OtherSupplier Development Engineer

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Quick Summary

Key Responsibilities

Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g.,

Technical Tools

OtherSupplier Development Engineer

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.

Responsibilities

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Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
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Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
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Collaborate with first & second-tier suppliers on process development and process validation including IQ/OQ/PQ/TMVs.
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Initiate and execute part qualification plan and reports.
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Train, coach, and guide lower-level employees on more complex procedures
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Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work
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Lead and establish complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
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Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
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Lead supplier related notification of changes (NOCs) including end of life (EOL) components and sub-assemblies to maintain fluid supply chain of finished products.
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Responsible for inspection method fixture development and implementation at contract manufacturer’s receiving inspection & sub-tier suppliers’ outgoing inspection.
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Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
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Collaborate with internal cross-functional teams, including Regulatory, Quality, Supply Chain, and R&D.
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Able to identify appropriate equipment, develop inspection methods, and fixtures to inspect or test Critical-to-Quality features. Perform appropriate Gauge Studies and statistical analysis to verify acceptability.
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Ability to read, interpret and modify 2D drawings & 3D CAD to ensure manufacturability and serve as a conduit between supplier and design teams.
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Demonstrate structured problem-solving approach for technical and logistical issues.
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Other incidental duties

Requirements

Bachelor's Degree in Engineering required; Biomedical Engineering or Mechanical Engineering preferred.
Minimum of 4 years of relevant engineering experience with a Bachelor's Degree, or 3 years of relevant engineering experience with a Master's Degree.

Proven expertise in usage of MS Office Suite, including MS Project; CAD experience preferred (if applicable).
Strong documentation, communication (written and verbal), and interpersonal relationship skills, including consultative and relationship management skills.
Basic understanding of statistical techniques.
Previous experience working with lab and/or industrial equipment required (if applicable).
Substantial understanding and knowledge of engineering principles, theories, and concepts.
Strong problem-solving, organizational, analytical, and critical-thinking skills.
Substantial understanding of processes and equipment used in assigned work.
Experience with Design of Experiments (DOE) and manufacturing process improvement preferred.
Experience supporting manufacturing line setup, optimization, and troubleshooting preferred.
Experience working directly with suppliers and external partners.
Good leadership skills and ability to influence change.
Knowledge of applicable FDA regulations for the medical device industry.
Strict attention to detail.
Ability to interact professionally with all organizational levels, suppliers, and external stakeholders.
Ability to manage competing priorities in a fast-paced environment.
Demonstrated ability to resolve conflicts and drive solutions through collaboration and effective communication.
Must be able to work in a team environment, including inter-departmental teams, and serve as a key contact representing the organization on contracts, projects, and supplier initiatives.
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others, as well as protecting the environment and preventing pollution under their span of influence and control.

What We Offer

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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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.