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Manufacturing Engineer

Medical Engineering Consultants (MEC)
Marlborough, MA Contractor
POSTED ON 3/8/2025
AVAILABLE BEFORE 4/6/2025
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

JOB TITLE: Manufacturing Engineer

Hybrid - 3 required days onsite.

Extension possible

Possibility of temp to hire for right individual, and if budget allows.

Job Purpose

Review and troubleshoot manufacturing validations. Supports or leads initiatives for the daily support of products, processes, materials and equipment in order to achieve production goals i.e. quality, delivery, cost, productivity and safety.

Key Responsibilities

  • Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain and Marketing on complex projects to ensure project success.
  • Consistently generates innovative and unique solutions to support process and equipment validation.
  • Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology, development and testing of materials or products, preparation of specifications, Six Sigma process study capability improvements and report preparation.
  • Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
  • Summarizes, analyzes and draws conclusions from complex test results.
  • Designs and prepares complex reports and communicates results to the technical community.
  • Designs and coordinates complex engineering tests and experiments.
  • Coordinates, manages and documents project goals and progress and recommends appropriate revisions.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests for products or equipment.
  • Completes and manages complex Capital Equipment Request Authorizations CERAs.
  • Leads cross-functional project teams.
  • Leads in the identification implementation and management of production goals.
  • Trains, develops and/or provides work direction to operators technicians and engineers.

Quality Systems Duties And Responsibilities

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications

  • 4 - 8 Years with BS
  • 3 - 6 Years with MS
  • Must have longevity in manufacturing engineering experience
  • Hands on validation experience required!
  • Validations, TMVs
  • Documentation reviews
  • Manufacturing development
  • Change reviews
  • Risk assessments
  • CM / OEM experience
  • Jabil Supplier experience/familiarity

Additional Job Specific Requirements

Travel up to 25% -will need Passport

Travel to Dominican Republic up to 1 week per month

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

  • Sponsorship is not available for this position

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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