Supplier Development Engineer II
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-07-24
Listing for:
Becton Dickinson
Full Time
position Listed on 2026-07-24
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Responsibilities
- Lead the identification and implementation of opportunities to optimize and improve manufacturing processes using engineering methods such as Six Sigma and Lean, and technical design skills.
- Drive the development and execution of experiments and tests—writing and executing protocols on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
- Collaborate with first‑ and second‑tier suppliers on process development and validation, including IQ / OQ / PQ / TMVs.
- Initiate and execute part qualification plans and reports.
- Establish project plans to ensure deliverables are completed to customer expectations, using project‑management tools such as project plans and risk analysis.
- Analyze and resolve manufacturing and compliance issues (CAPA, non‑conformances, audit observations).
- Lead supplier‑related notifications of changes (NOCs), including end‑of‑life components and sub‑assemblies, to maintain a fluid supply chain.
- Develop inspection‑method fixtures, implement and qualify inspection methods at contract manufacturer receiving inspection and sub‑tier suppliers’ outgoing inspection.
- Develop training and documentation materials (work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
- Collaborate with cross‑functional internal teams—Regulatory, Quality, Supply Chain, and R&D.
- Identify appropriate equipment, develop inspection methods and fixtures to inspect or test critical‑to‑quality features.
- Perform gauge studies and statistical analysis to verify acceptability.
- Read, interpret, and modify 2D drawings and 3D CAD to ensure manufacturability and serve as a conduit between supplier and design teams.
- Demonstrate a structured problem‑solving approach for technical and logistical issues.
- Perform other incidental duties as required.
- Education:
Bachelor’s degree in engineering (preferred Biomedical, Mechanical, or Automotive). Master’s degree or equivalent in Engineering and 2 years’ experience is also acceptable. - Experience:
3 years’ industry experience (or industry/education) or 2 years’ if holding a Master’s degree. - Technical skills:
Proficient use of MS Office Suite, MS Project; CAD experience preferred. - Documentation, communication, and interpersonal skills—including consultative and relationship‑management abilities.
- Basic understanding of statistical techniques.
- Experience working with laboratory or industrial equipment.
- Strong problem‑solving, organizational, analytical, and critical‑thinking skills.
- Minimal understanding of processes and equipment used in assigned work.
- Knowledge of applicable FDA regulations for the medical device industry.
- Strong attention to detail.
- Professional interaction across all organizational levels.
- Ability to manage competing priorities in a fast‑paced environment and work effectively in cross‑departmental teams.
Annual Salary: $83,500.00 – $ USD.
Equal Employment Opportunity StatementBecton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
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