Mechanical LCM Engineer

Job Title

Mechanical LCM Engineer - Urgent Need

Millennium Soft Inc

Irvine, CA

Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT), HYBRID

Mechanical LCM Engineer

12 Months

40.00

1st Shift, NO OVERTIME planned/required

Medical Devices Company

Industrial

The (Mechanical) LCM Engineer is an exciting opportunity to collaborate on projects and initiatives in support of client 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 optimize/improve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN) and re‑design 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 the 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, and process excellence methodologies).
• Support key project initiatives (supplier transfers, part changes, system enhancements, line extensions, cost reductions, labor 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, collaborating with the team to refine triage criteria and improve efficiency.
• Deploy, review, and act upon meaningful metrics to measure, control, define, refine, and optimize processes and for process control and continuous improvement.
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze 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 the seamless knowledge transfer of project and manufacturing processes.
• Lead and establish project plans to ensure deliverables are completed to the 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. OR Master’s Degree or equivalent in Engineering or Scientific field with 4 years’ experience including either industry or industry/education. OR Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education.

• Proven expertise in usage 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 (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 understanding and knowledge of principles, theories, and concepts relevant to Engineering and best practices.
• Strong problem‑solving, organizational, analytical and critical thinking skills.
• Substantial…