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    Sr. Manufacturing Engineer - San Jose, United States - Noah Medical

    Noah Medical
    Noah Medical San Jose, United States

    2 weeks ago

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    Description


    The Senior Manufacturing Engineer is responsible for sustaining and identifying and implementing continuous process improvements with an emphasis on process validation.

    The position will be responsible for on-demand production line support, measure manufacturing driven metrics (cycle times, capacity, bottlenecks etc.), design, duplicate and/or deploy manufacturing fixtures and tooling, develop and train on manufacturing processes and perform equipment qualification and process validation activities.

    A
    Day In The Life Of Our Senior Manufacturing Engineer:

    Be a leader in process validation (IQ/OQ/PQ/PPQ) for the team, developing the protocols and test processes


    Provide daily support to troubleshoot and resolve manufacturing production issues including material, method, while following GMP and the company Quality Management System.

    Create and revise manufacturing-related risk documents including pFMEA's and Manufacturing Line Specifications


    Identify root cause(s) of operational failures and support Corrective and Preventive Action plans by providing solutions using problem-solving skills including Fishbone, 5 Whys, Pareto Charts etc.

    Generate production metrics including yields, scrap rates, capacity/bottlenecks and cycle times and routinely present to management.

    Define and implement continuous process improvements to existing manufacturing operations including process verification, MFG documentation updates and process validation.

    Perform routine equipment preventative maintenance and/or repair and serve as manufacturing liaison for external calibration activities.

    Design, document, assemble, qualify and release custom and off the shelf manufacturing and testing tooling, fixtures and equipment. Create and release associated maintenance and calibration procedures.

    Author and execute manufacturing documentation, including protocols, reports, manufacturing process instructions, work instructions and equipment/fixture specifications.

    Other manufacturing engineering duties or support as assigned or requested.


    This role requires the use of varying levels of personal protective equipment (including, gowns, masks/face shields, gloves, and safety glasses).


    About You:
    Degree in Manufacturing/Industrial, Mechanical, or Electrical Engineering

    Minimum 5 years experience in the medical device industry in a manufacturing engineering capacity working with complex hardware/software devices

    Catheter experience is a plus

    Experience in working with CM, especially an OUS CM

    Working knowledge of ISO 13485 and 21 CFR 820.

    Understanding of statistical methods

    SolidWorks or equivalent experience

    Proficient with standard business software (MS Office, Excel, Outlook etc.)

    Excellent written and oral communication skills are required


    Workplace Type:
    Onsite

    Benefits & Perks (For Full Time Employees):

    Competitive Salary

    Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options

    Equity & Bonus Program

    Life Insurance (company paid & supplemental) and Disability insurance

    Mental health support through medical insurance programs

    Legal and Pet Insurance

    12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days

    Paid parental leave

    In-office snacks and beverages

    In-office lunch stipend

    Learning & Development Opportunities:
    On-demand online training and book reimbursement

    Team building and company organized social and celebration events

    #J-18808-Ljbffr
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