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Manager, Manufacturing Engineering

Job Snapshot
Location:
7 Jackson Road
Boston, MA 01434
Employee Type:
Full-Time
Industry:
Medical Equipment
Manufacturing
Manages Others:
Yes
Job Type:
Engineering
Manufacturing
Education:
4 Year Degree
Experience:
7 to 10 years
Travel:
Negligible
Post Date:
11/5/2009
Description
Manager, Manufacturing Engineering


Summary of Manager, Manufacturing Engineering

The Manager, Manufacturing Engineering will organize and supervise the activities of Manufacturing Engineering. Through the appropriate staff, is responsible for working with Sales and R&D in managing all new manufacturing/engineering product initiatives from concept through design phases, equipment enhancements, equipment design and build, to successfully transfer to Manufacturing. Provides technical support to existing manufacturing related process development initiatives.

Responsibilities of Manager, Manufacturing Engineering

Manage department headcount and resources to meet manufacturing engineering support needs Key duties and responsibilities include:

  • Support R&D and Sales in the development of new product initiatives and specifications.
  • Keep all product initiatives organized, on schedule and within budget.
  • Provide a smooth transfer of new products, processes and equipment into manufacturing, ensuring adequate documentation and training.
  • Support sales efforts as the primary technical resource where appropriate, including customer interactions, visits, and presentations.
  • Contribute in the technical reviews of new products to evaluate viability and functionality.
  • Responsible for generation and ensuring execution of IQ, OQ and PQ validation protocols for new products, equipment and processes.
  • Assist in generation of technical and functional specifications of new capital equipment.
  • Support and document process, material or procedure changes using appropriate Bionostics quality system elements (SOP's, CAPA, ECO's, Risk Analysis etc.).
  • Maintain and ensure execution of Facility and Equipment preventative maintenance programs.

Requirements
Manager, Manufacturing Engineering

Requirements for Manager, Manufacturing Engineering

  • Bachelors degree (Chemical background preferred) in a related field or equivalence in accumulated work experience.
  • Minimum of 7-10 years engineering experience, 5 of which are medical device or other FDA regulated manufacturing environment.
  • Must have strong leadership and decision-making skills with the ability to work cross-functionally in challenging situations both internally and externally (with customers and suppliers).
  • Strong problem solving skills with good experimental and documentation knowledge.
  • Must possess strong verbal, communication, and computer skills.
  • Must have good multitasking skills with the ability to work in a dynamic environment.
  • Detail oriented with a high level of emphasis on accuracy, completeness and meeting deadlines.
  • Comprehensive understanding and interpretation FDA QSR's and ISO requirements as applied to medical device manufacture.
  • Understanding of BOM/Recipe structures and process flow activities.

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