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
