Bausch Health

  • Sr. Mfg Engineer

    Job Location US-WA-Bothell
    Job ID
    11334
    Pos. Category
    Operations
    Pos. Type
    Full Time
  • Overview

    This position has a lead role in the development, validation, and maintenance of processes and equipment that support Production.  This person selects production equipment, develops custom equipment and processes as required to produce Solta products.  This position is the primary contact for Production, Product Development, and suppliers as related to process issues.

    Responsibilities

    • Manages process development activities including: planning, process definition, process limit definition, process failure mode effects analysis, process validation planning and execution, and any process related documentation.
    • Establishes and maintains production process roadmap.
    • Works within a cross-functional development team to define and design new products.
    • Works with Product Development to define production processes during development
    • Works with Product Development to ensure manufacturability of products.
    • Participates in and holds design reviews.
    • Participates in supplier and subcontractor selection, qualification, and CAPA efforts.
    • Leads the design transfer from engineering to manufacturing.
    • Performs production capacity planning and manufacturing line layout activities.
    • Develops and maintains manufacturing assembly instructions, tooling, and other aids to ensure a controlled and efficient manufacturing process.
    • Develops process and equipment verification and validation plans, reports, etc.
    • Lead production equipment selection process.
    • Creates and maintains all end item BOM structures and production routes.
    • Performs cost analysis and implements cost reduction plans.
    • Performs data analysis and trending on manufacturing processes.
    • Initiates root-cause analysis and troubleshooting and improvement activities to increase quality and yields, and reduce cost.

    Qualifications

    Experience, Education, Training, Traits:

     

    • BS in Mechanical Engineering or Electrical Engineering, related field, or equivalent experience.
    • Minimum 5 Years’ experience in a medical device capital equipment manufacturing environment.
    • Demonstrated ability to utilize and implement lean manufacturing concepts. Including but not limited to; 5S visual workspace planning, value stream mapping, kaizen event leadership.
    • Experience in new process and product development and transfer to manufacturing.
    • Demonstrated ability to set up manufacturing lines and processes.
    • Experience assessing process variables utilizing a process failure modes effects analysis (PFMEA).
    • Demonstrated ability to verify and validate production processes and equipment.
    • Experience in a box build manufacturing environment.
    • Demonstrated ability to drive production process improvement through equipment, methods, and design.
    • Demonstrated ability to utilize SPC and design of experiments to drive change.
    • Demonstrated ability to drive DFM improvement into product designs during development.
    • Working knowledge of medical device FDA QSR's and ISO9001 requirements.

     

    Desired skills:

    • Experience troubleshooting electronic equipment
    • Experience with the following processes: casting, bonding, plasma etch, mixing, curing, and ultrasonic welding.
    • Background in RF and laser equipment and/or diagnostic or therapeutic ultrasound.
    • Demonstrated ability to coach and train production personnel.
    • Strong PC skills required – Word, Excel, etc.
    • Experience with Pro Engineer a plus.

     

    Language and Verbal Skills

    Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.  Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.

     

    Math Skills

    Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.  Ability to use MS Excel to perform calculations and interpret project results/data.

     

    Analytical and Reading Skills

    Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.  Ability to read regulatory, technical and clinical literature and documents and extract important concepts.

     

    Physical Requirements

    While performing the duties of this job, the employee may be required to perform lifting tasks of up to 30 pounds for short durations.  Duties of this job may involve standing and/or walking for extended periods of time.  Duties also involve daily keyboard data entry.  Specific vision abilities required by this job include close vision.

     

    Work Environment

    The work environment is office and light manufacturing.  The noise level in the work environment is usually moderate.  Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.

     

     

     

    Safety

    Solta Medical is committed to the health and safety of our employees.   We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

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