Mechanical Engineer

Job Title: Mechanical Engr 2

Location: Irvine, CA 92618

Duration: 12 months contract (Temp to Perm possibility)

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

The Mechanical LCM Engineer is an exciting opportunity to collaborate on projects and initiatives in support of Becton Dickinson's Advanced Patient Monitoring (BD APM) systems.

This position will play a key role in the development and execution of the manufacturing and operations strategy, including supporting key projects and initiatives, ongoing manufacturing, new product commercialization, line extensions, interfacing with third party providers, and leading product and process improvements.

• Identify and ensure implementation of opportunities to optimise/improve manufacturing processes using engineering methods such as Six Sigma and Lean methods, employing technical design skills to re‑design/ redesign to ensure parts, equipment, tools, fixtures, etc. are up to standards.
• Use technical principles, problem‑solving skills, and data analysis to support and problem‑solve for production at contract manufacturer.
• Work and lead initiatives to support manufacturing projects and goals (material qualification, supplier/label/part/product changes, product enhancements, equipment qualifications, tolerance stack analysis through technical advancements, problem‑solving skills, and process excellence methodologies).
• Support key project initiatives (supplier transfers, part changes, system enhancements, line extensions, cost reductions, labour‑efficiency improvements, and quality and compliance excellence).
• Manage change control for ongoing manufacturing changes, including CAD updates, change requests, process changes, Device Master Record, product specifications, test processes, and product service processes.
• Review all incoming PCNs and assess any changes (material, mechanical, electrical, datasheet, etc.).
• Route PCNs with relevant changes to designated product owners.
• Maintain a tracking system for PCNs reviewed, routed, and approved, and collaborate with the team to refine triage criteria and improve efficiency.
• Deploy, review, and act upon meaningful metrics to measure, control, define, refine, and optimise processes and for process control and continuous improvement.
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reports.
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non‑conformances, audit observations).
• Develop training and documentation materials (e.g., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes.
• Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Other incidental duties assigned by Leadership.

• Bachelor's Degree in Engineering or Scientific field with 5 years' experience including either industry or industry/education Required.
• Master's Degree or equivalent in Engineering or Scientific field with 4 years' experience including either industry or industry/education Required.
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required.

• Proven expertise in use of MS Office Suite including MS Project.
• Proven expertise/knowledge using Windchill PLM. Teamcenter also preferred.
• Ability to use Mechanical CAD tools (Solid Works, CREO, ProE).
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment (if applicable).
• Substantial…