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Process Development Engineer II

Billerica, MA 01821

Posted: 06/04/2024 Employment Type: Contract Job Category: Engineering Job Number: 607581 Is job remote?: No Country: United States

Job Description

As a Process Development Engineer II, you will develop new manufacturing processes, implementing and qualifying production equipment and methods, managing development builds, generating testing protocols and reports, and working to drive continuous yield improvement.


Responsibilities will include but are not limited to:
  • Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for yield improvement projects through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies.
  • Develop fixtures, tooling, and equipment.
  • Develop process specifications which ensure user needs are met.
  • Perform process characterizations and qualifications (IQ/OQ/PQ).
  • Manage required builds for yield improvement projects in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues. 
  • Comply with applicable FDA and international regulatory laws/standards.
  • Perform other duties as assigned or required.


Nice to Have
  • 2+ years of experience developing products and/or manufacturing processes in the medical device industry
  • Knowledge of SolidWorks and engineering statistics
  • Some experience or knowledge with Coils/Stents/Braid Manufacturing processes such as laser cutting, laser welding (similar/dissimilar materials), heat setting, electropolishing, braiding, crimping, swaging, cleaning processes, etc.
  • Experience with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design).
  • Knowledge of design and process FMECA, process validation, and process control.
  • Knowledge of design for manufacturability and lean methodologies.
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About Billerica, MA

Discover your next career opportunity in the vibrant area surrounding Billerica, Massachusetts! This bustling region offers a perfect blend of scenic beauty, historic charm, and abundant growth opportunities. From the picturesque hikes at Great Brook Farm State Park to the buzzing arts scene at The Brush Art Gallery and Studios, Billerica and its surroundings have something for everyone. Immerse yourself in the rich culture of the area, savor the local delicacies like freshly caught seafood and signature Boston cream pie, and catch a game at the iconic Fenway Park while working in this dynamic and exciting region. Explore our job listings today and take the next step towards a fulfilling career in this captivating area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.