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Senior Manufacturing Engineer

ACE Partners
Tewksbury, MA Full Time
POSTED ON 3/4/2025
AVAILABLE BEFORE 6/4/2025

Senior Manufacturing Engineer Medical Device Production $90k - $120k

Tewksbury, MA

US Citizens or Green Card holders only

No C2C

We are seeking a hands-on Senior Manufacturing Engineer to lead and optimize manufacturing processes for innovative single-use medical devices.

This role offers an opportunity to drive efficiency, quality, and scalability in a dynamic, growth-oriented company.

Key Responsibilities :

  • Develop, implement, and refine manufacturing processes to enhance efficiency, quality, and cost-effectiveness.
  • Lead process verification and validation to support commercial production launches.
  • Address and resolve non-conformances through the NCR / CAPA system.
  • Optimize workflow and facility layout for improved safety and productivity.
  • Establish standardized work procedures and equipment operating parameters.
  • Collaborate with product development teams on tooling, fixtures, and automation solutions.
  • Troubleshoot equipment issues and implement process improvements.
  • Drive cost reduction initiatives and minimize material waste.
  • Work with Quality Control to resolve supplier-related quality concerns.
  • Develop capital equipment proposals for process scaling and advancements.
  • Ensure alignment of manufacturing objectives with validation, clinical trials, and product launch timelines.
  • Delegate tasks effectively and track project performance.
  • Manage budgets and optimize resource allocation.
  • Develop and present project plans and timelines to cross-functional teams.

Qualifications :

  • Bachelors degree in manufacturing, Mechanical, Industrial, or Plastics Engineering.
  • 8 years of experience in equipment-intensive manufacturing, preferably in an ISO 9000 environment.
  • Proven project management skills with a record of driving successful outcomes.
  • Proficiency in SolidWorks for fixture and tooling design preferred.
  • Experience in plastics processing (extrusion, injection molding, fiber forming) is a plus.
  • Familiarity with ISO 13485 standards is advantageous.
  • Strong organizational and leadership skills.
  • Excellent communication and adaptability in dynamic environments.
  • Salary : $90,000 - $120,000

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