Senior Manufacturing/Mechanical EngineerApply Now
Location: Waltham, Massachusetts 02452
Employment Type: Contract
Contract Length: 3-6 months
Job Summary: Provides technical and engineering support to the Operations department. Coordinates Engineering Tech staff and activities in production areas. Supports New Product Introduction as the site project lead. Designs equipment and floor layouts
- Project management
- Equipment and process improvement projects,
- Support the introduction of new processes or equipment into the manufacturing facility
- Facility equipment maintenance, calibration, and troubleshooting
- Lead investigational activities around non-conformances
- Operator training and operating procedure/batch record development
- Create and develop CAD drawings
- Act as the subject matter expert (SME) for assigned product lines which includes supporting audit activities and first response for shop floor alerts. Support shop floor activities and work with operators as required to complete daily operational targets.
- Bachelor’s Degree in engineering or equivalent professional experience
- 10 years of experience in the Medical Device industry or Pharmaceutical industry within a clean room environment
- Mechanical Aptitude
- Ability to read blueprints, electrical & pneumatic schematics
- Ability to assess tolerances and make design for manufacturability recommendations
- Excellent verbal and written communication skills
- Strong technical writing abilities
- Must possess strong leadership skills with team-focused attitude and approach.
- Excellent troubleshooting and problem-solving skills
- Time management oriented with the ability to support overtime activities to meet project objectives
- Demonstrated computer knowledge of Microsoft Office and Microsoft Project
- Must read, write and speak in English, and communicate clearly and concisely
- Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.
- Understanding of Lean/six Sigma a plus.
- CAD experience (AutoCAD) a plus
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