Senior Manufacturing Engineer Job at ACE Partners, Costa Mesa, CA

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  • ACE Partners
  • Costa Mesa, CA

Job Description

Medical Devices - Senior Manufacturing Engineer II (Electrical) $105k - $120k

US Work Eligibility: US Citizen or Green card holders only

We are seeking a Senior Manufacturing Engineer II to enhance the design, manufacturing, and assembly processes and to optimize the production of implantable components, ensuring compliance with design specifications and regulatory standards.

RESPONSIBILITIES:

  • Lead design-for-manufacturing (DFM) reviews and optimize processes with key vendors.
  • Develop and validate manufacturing processes from prototype to production:
  • Select, design, install, and validate equipment.
  • Streamline costs and enhance supply chain efficiency.
  • Define and ensure product output specifications.
  • Plan, coordinate, and execute detailed manufacturing phases:
  • Collaborate with technicians and stakeholders.
  • Review and maintain 2D/3D CAD designs.
  • Apply GD&T analysis per ASME Y14.5 and Y14.100 standards.
  • Create work instructions covering process time, capacity, and workflows.
  • Oversee design transfer to manufacturing
  • Manage schedules, procurement, vendor relations, and manufacturing environments.
  • Verify products and processes using statistical controls and ensure traceability.
  • Develop test plans to meet design and output specifications.
  • Perform failure analysis and implement corrective actions.
  • Conduct risk analysis and manage suppliers through production.
  • Support regulatory submissions with detailed documentation.

REQUIREMENTS:

  • Bachelor’s in Mechanical, Electrical, Biomedical, or Manufacturing Engineering (Master’s preferred).
  • 3–5 years of experience in product/process development and manufacturing engineering (medical device industry preferred).
  • Strong knowledge of process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs.
  • Familiarity with ISO 13485, FDA quality systems, and design controls.
  • Experience in logistics and supply chain management is a bonus.
  • Proficiency with industry best practice and standards.

Do you want the chance to work on life-saving technology in a multidisciplinary, fast-paced environment?

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