Senior Manufacturing Engineer – Medical Devices

1 week ago

cambridge, United States Intellectt Inc Full time

Hi All,

One of my clients is looking Role: Manufacturing Engineer, if you’re interested or your skills matches, please share with me your updated resume to sohail@intellectt.com


Job Title: Manufacturing Engineer - Medical Device

Location: Cambridge, MA

Employment Type: Contract (Onsite)

Visa: Any Visa


Job Description

Overview:

We are seeking a Senior Manufacturing Engineer for an onsite contract role based in Cambridge, MA. The ideal candidate will collaborate with R&D, Pilot, and commercial manufacturing teams, playing a key role from Early Human Use through the commercialization of new medical device products. The role focuses on ensuring robust, scalable, and regulatory-compliant manufacturing processes that utilize Lean Six Sigma, Design for Manufacturing (DFM), and Design for Cost methodologies. This position also requires acting as a liaison between multiple cross-functional teams, including R&D, Supplier Development, Quality, and Operations.

Key Responsibilities:

  • Develop and optimize cost-effective, validated manufacturing processes for medical devices, focusing on capital and disposable devices (e.g., assembly, lot release testing, sterilization, packaging).
  • Create production-level assembly and part drawings for all components and sub-assemblies.
  • Incorporate DFM, Six Sigma, and LEAN principles into product designs to ensure manufacturability, minimize costs, and optimize production efficiency.
  • Identify and evaluate potential contract manufacturing partners, analyzing quality, cost, delivery timelines, and regulatory compliance.
  • Lead collaborations with contract manufacturers, selecting efficient manufacturing processes and sites.
  • Serve as a liaison between the Contract Manufacturing Organization (CMO) and the company to coordinate manufacturing activities.
  • Review engineering product specifications and CAD drawings, ensuring alignment with industry and manufacturing standards.
  • Oversee part/drawing releases and ensure accuracy in the Bill of Materials (BOM).
  • Develop and execute complex experiments to validate manufacturing processes, analyze results, and make recommendations.
  • Perform Characterization and Validation activities, including CTQ flow-down and identification of critical control points in manufacturing.
  • Lead manufacturing risk assessment and develop mitigation strategies.
  • Create and maintain manufacturing work instructions, equipment instructions, and other controlled documents within the quality management system.
  • Coordinate technical communications between internal teams and contract manufacturers for design transfer.
  • Provide expertise in pFMEA and process validations.
  • Share knowledge of Lean Six Sigma and process improvement methodologies.
  • Collaborate with cross-functional teams (e.g., mechanical, optical, electrical, software engineers, quality and regulatory specialists, clinical teams, marketers, and buyers).

Expected Deliverables:

  • Develop and maintain a project task list for DFM activities.
  • Create and update BOMs, work instructions, and travelers.
  • Create and maintain pFMEA documentation.

Required Qualifications:

  • Experience with electromechanical medical devices, particularly with cart/console systems.
  • Strong background in Design for Manufacturing (DFM), Lean Six Sigma, and process optimization for medical devices.
  • Proven ability to work cross-functionally and coordinate with contract manufacturers.
  • This is a great opportunity to work in a collaborative environment and contribute to the development of advanced medical devices, ensuring they meet both technical and regulatory standards

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