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    Mechanical Design Engineer - Thousand Oaks, United States - ACL Digital

    ACL Digital
    ACL Digital Thousand Oaks, United States

    2 weeks ago

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    Description

    Job Title: Senior Mechanical Design Engineer

    Location: Thousand Oaks, CA

    Duration: 18 months contract

    Description:

    Hybrid - MUST BE LOCAL TO USTO

    Monday, Wednesday, Friday (Remote)

    Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am- 4pm

    Looking for a candidate who has not job hopped every 6-8 months and has a solid root cause analysis skills, technical writing, statistical background, CAD skills, thinker, problem solver, etc

    Mainly Mechanical, Manufacturing, Biomedical engineers. Coding skills is a plus but not required. Candidates experience with Instron (or any other Force Tester), Keyence is a huge plus. Not so much candidates with QA/QE background they are usually good with documents and statistics and not so much a problem solver or overall technical.

    Top 3 Must Have Skill Sets:

    EM FEEDBACK- Looking for a candidate who has not job hopped every 6-8 months and has a solid root cause analysis skills, technical writing, statistical background, CAD skills, thinker, problem solver, etc

    Mainly Mechanical, Manufacturing, Biomedical engineers. Coding skills is a plus but not required. Candidates experience with Instron (or any other Force Tester), Keyence is a huge plus. Not so much candidates with QA/QE background they are usually good with documents and statistics and not so much a problem solver or overall technical.

    Top 3:

    Experience performing data analysis using statistical software, (JMP, Minitab)

    Experience modeling test fixtures, reference samples on solidworks or any other CAD software

    Root cause analysis, CAPA deviation

    Equipment method and test validation experience

    Technical writing experience

    RESPONSIBILITIES:

    Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.

    Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.

    Apply core engineering principles to develop physical test methods for medical device and combination product systems.

    Perform data analysis to support method development, qualification, validation, and transfer

    Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.

    Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).

    Coordinate gauge and equipment development and delivery with selected contractors.

    Ensure that qualification parameters are met for product assembly and performance requirements.

    Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.

    Generate procedures necessary to support department and new product equipment.

    Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).

    Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.

    Excellent communication (written and verbal) and organizational skills

    Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables

    Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen

    Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.

    Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently

    Integrates partner/vendor timelines with Amgen timelines as appropriate

    Basic Qualifications:

    Doctorate Degree OR

    Master's Degree and 3 years of Engineering experience

    OR Bachelor's Degree and 5 years of Engineering experience

    OR Associate's degree and 10 years of Engineering experience OR

    High school diploma/GED and 12 years of Engineering experience.

    Preferred Qualifications:

    M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering

    Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment

    Experience with managing technical teams, including setting priorities and leveling resources

    Technical writing experience

    Spanish language skills preferred

    Experienced with SolidWorks (or other 3D-CAD software)

    Familiar with equipment and software IOQ

    Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs

    Experience with change controls, deviations, CAPA

    Experience with combination products and device regulatory requirements

    Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems

    Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing

    Experience with machine controls (PLC, HMI) and vision systems

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