Sr. Manufacturing Engineer, Cambridge MA - Confidential

Job Description:
We are looking on behalf of our clients for a hands-on Sr. Manufacturing Engineer with specific expertise in cart systems, console operations, and electromechanical devices. The ideal candidate will have demonstrated experience in managing, maintaining, or improving these systems. This role requires collaboration between Research & Development (R&D), pilot manufacturing, and commercial production teams to take innovative products from early human use to commercialization. You will ensure that the manufacturing processes are scalable, robust, and compliant with regulatory requirements, while also implementing LEAN Six Sigma, Design for Manufacturing (DFM), and Design for Cost Methodologies. This role acts as a key liaison between R&D, Supplier Development, Quality, and Operations teams.

Key Responsibilities:
- Develop and optimize efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on both capital and disposable devices.
- Produce production-level assembly and part drawings for components and sub-assemblies.
- Incorporate DFM, Six Sigma, and LEAN principles to ensure manufacturability and cost efficiency.
- Identify and evaluate potential contract manufacturing partners, analyzing quality, cost, and compliance.
- Lead collaborations with contract manufacturers to ensure efficient manufacturing processes and strong partnerships.
- Coordinate between Canon and Contract Manufacturing Organizations (CMOs) to streamline manufacturing activities.
- Review engineering specifications and CAD data to ensure industry compliance.
- Drive the development and execution of experiments and tests for new and existing product lines.
- Manage validation activities, including risk assessments and manufacturing work instructions.
- Provide technical expertise in process validation and pFMEA development.
- Collaborate with cross-functional teams across various disciplines including optical, electrical, and software engineering.

Expected Deliverables:
- Development and maintenance of project task lists for DFM activities.
- Creation and maintenance of BOMs, work instructions, and travelers.
- Development and upkeep of process FMEA.

Qualifications:
- Bachelor’s degree or higher in Mechanical Engineering.
- 5+ years of experience in medical device manufacturing, including at least three years of experience in new product development, design transfer to production, and process validation.
- Proficiency in SolidWorks, especially in assemblies with dozens of parts.
- Experience working with contract manufacturers in capital equipment, electronics testing, or catheter manufacturing.
- Knowledge in DFM, Six Sigma, LEAN, cGMP, and process validation.
- Proficiency with Microsoft Office Suite and statistical analysis software (Minitab, JMP).

Nice to Have:
- Lean and/or Six Sigma certifications.

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