Job Description
One Life Science is working with a Medical Device company that is a , innovative medical device manufacturer dedicated to developing life-changing technologies that improve patient outcomes.
Position Overview
We are seeking a Manufacturing Engineer with at least 4 years of experience in the medical device industry and a solid background working with machine shop operations. This role will support production scale-up, process optimization, and manufacturing readiness for new and existing Class I and II medical devices
Key Responsibilities
- Support and improve existing manufacturing processes to ensure consistent product quality and compliance with FDA, ISO 13485, and other regulatory standards.
- Collaborate with R&D and Quality teams to transition new products into production (NPI).
- Design, document, and implement assembly and inspection procedures, fixtures, and jigs.
- Provide hands-on support in the machine shop for prototype fabrication, tooling, and maintenance.
- Drive root cause analysis and implement corrective actions for production issues using tools such as 5 Whys, FMEA, and fishbone diagrams.
- Monitor and report on manufacturing metrics (yield, downtime, scrap) and identify areas for cost and efficiency improvements.
- Train and support manufacturing technicians on new processes, tools, and safety procedures.
- Maintain accurate documentation (SOPs, work instructions, process validations, DMRs).
Qualifications
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
- Minimum 4 years of experience in a manufacturing engineering role within the medical device industry.
- Strong understanding of FDA QSR, ISO 13485, and medical device documentation and validation practices.
- Hands-on experience with machine shop equipment (mills, lathes, grinders, CNCs) and the ability to read and interpret technical drawings and GD&T.
- Experience with lean manufacturing principles, Six Sigma tools, and process validation (IQ/OQ/PQ).
- Proficiency in CAD software (SolidWorks ).
- Excellent communication skills and the ability to work cross-functionally in a fast-paced environment.
Qualifications
- Experience supporting electromechanical systems.
- Certification in Six Sigma or Lean Manufacturing.
- ERP/MRP experience (SAP, Oracle, or equivalent).
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