Senior Manufacturing Engineer

1 week ago

Danvers, United States Spectrum Staffing ServicesHRStaffers Inc. Full time

SUMMARY

Plans and coordinates work to higher level project schedules; develops longer term plans under guidance; analyzes complex problems independently, coordinates cross-functional development and supplier work. Responsible for creating, documenting, developing and implementing procedures used to assemble, process, test and /or manufacture products. Will design, implement, monitor and maintain manufacturing processes. Consult with design engineers to achieve the most efficient and cost-effective way of producing the highest quality product possible.


RESPONSIBILITIES

  • Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and corporate guidelines.
  • Estimate production times, staffing requirements, and related costs to provide information for management decisions.
  • Confers with management and other staff regarding manufacturing capabilities, production schedules and other considerations to facilitate production processes.
  • Apply statistical methods to trouble shoot processes and conduct root cause analysis.
  • Improve existing operations, incorporating new methods, processes and training.
  • Handle equipment purchase and installation, perform IQ/OQ and PQ functions.
  • Investigate operational problems affecting production and deal with them in a systematic, methodical manner.
  • Prepare manufacturing documentation required for product manufacture.
  • Coordinate projects.
  • Identify ways to reduce production costs.
  • Work with R&D and other departments to produce cost estimates for new designs.
  • Work with regulatory bodies to ensure safety, environmental and design standards are met.
  • Serve as a team member in support of ‘design for manufacturability’.
  • Assist R&D in the transition of new products to production product status.
  • Generate and update assembly documentation (travelers/work instructions).
  • Process engineering changes (ECOs)
  • Control manufacturing costs by employing creative manufacturing and assembly methods (fixture design).
  • Determine and review product cost.
  • Provide production floor support.


QUALIFICATIONS

  • BS in mechanical or manufacturing engineering. Strong background in interpretation of Engineering drawings/specifications and manufacturing process planning/evaluation.
  • Prior experience in machine shop practices including milling, turning and grinding a plus.
  • Experience with Six Sigma.
  • Previous experience with automation a plus.
  • Experience with mechanical design using SolidWorks.
  • Minimum of 7 years of related experience – preferably in the medical device industry.
  • Excellent written and verbal communication skills. Prior experience in technical writing and procedure development.
  • Must have demonstrated ability to work as part of a team.
  • Strong analytical and problem solving skills.
  • Must be self-motivated.

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