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

NDJDTzFodmhtd1F5cGVMSGFDdEhCTG56Y0E9PQ==
  • 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?

Job Tags

Similar Jobs

CLevelCrossing

Chief of Staff to Chief Marketing Officer Job at CLevelCrossing

Chief of Staff to Chief Marketing Officer Location: San Jose, CA, United StatesPosted on: Aug 19, 2022ProfileJoin us as we pursue our disruptive new vision to make data accessible, usable, and valuable to everyone. We are a company filled with people who are passionate... 

Umanist Staffing LLC

Medical Device Assembler Job at Umanist Staffing LLC

Position: Medical Device Assembler, Operations - Shift 3 Location: Dublin, OH 43016 Duration: 12 Months Job Type: Contract Work Type: Onsite Shift: (Sun-Thur) (10.30 PM-7.00 AM) Job Description Responsibilities: -Assemble various... 

Aureus Medical Group - Imaging

Travel Ultrasound Technologist - $2,324 per week Job at Aureus Medical Group - Imaging

 ...Job Description Aureus Medical Group - Imaging is seeking a travel Ultrasound Technologist for a travel job in Portland, Oregon. Job Description & Requirements ~ Specialty: Ultrasound Technologist ~ Discipline: Allied Health Professional ~ Start Date: ASAP... 

Compass Group USA

Project Manager Job at Compass Group USA

 ...personal networks; participating in professional organizations Qualifications: ~ Bachelors degree required ~ Graduate degrees preferred - MBA/ CPA /MSOD ~ PMP, Lean Sigma, SCRUM, Agile certifications encouraged ~3+ years experience managing enterprise... 

QPS Employment Group

TIG Welder/ Fabricator Job at QPS Employment Group

 ...Position Title : TIG Welder/ Fabricator Wage : $20.00-$25.00/Hour Based on Experience Shift : 1st Shift Hours : 7:00AM-3:00PM; Monday- FridayWe are seeking a highly skilled TIG Welder/Fabricator for a direct-hire opportunity in Plymouth, WI! If you have...