Mechanical LCM Engineer - Irvine - MillenniumSoft Inc

    MillenniumSoft Inc
    MillenniumSoft Inc Irvine

    4 hours ago

    $75,000 - $150,000 (USD) per year *
    Description

    Job Title


    Mechanical LCM Engineer - Urgent Need

    Company


    MillenniumSoft Inc

    Location


    Irvine, CA

    Employment Type


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

    Position


    Mechanical LCM Engineer

    Duration


    12 Months

    Hours per Week


    40.00

    Shift


    1st Shift, NO OVERTIME planned/required

    Client


    Medical Devices Company

    Job Category


    Industrial

    Job Description


    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.

    Responsibilities

    • 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.

    Education and Experience

    • 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.

    Additional Skills

    • 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 (SolidWorks, 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 understanding of processes and equipment used in assigned work.
    • Good leadership skills and ability to influence change.
    • Knowledge of and adherence to BD Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
    • Knowledge of applicable FDA regulations for medical device industry preferred.
    • Strict attention to detail.
    • Ability to interact professionally with all organizational levels.
    • Ability to manage competing priorities in a fast paced environment.
    • Must be able to work in a team environment, including inter‑departmental teams.
    • Be a key contact representing the organization on contracts or projects with suppliers.
    • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
    • 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.

    Preferred

    • Familiarity with medical device regulations and governance documents (ISO13485, CFR820, etc.).
    • Lean Champion and/or Six Sigma certifications.
    • Ability to read electronics schematics and mechanical drawings.
    • Experience troubleshooting and documenting evaluations of finished devices, sub‑assemblies, and component failures.

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    * This salary range is an estimation made by beBee

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