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Production Process Engineer
2 months ago
CLIENT OVERVIEW:
Meet is excited to collaborate with a forward-thinking medical device organization focused on creating innovative solutions for the biosurgery sector.
ROLE SUMMARY:
We are seeking an experienced Manufacturing Engineer to oversee and optimize manufacturing operations by developing, assessing, and refining production techniques. This role requires leveraging your expertise in product design, materials, fabrication processes, tooling, production equipment capabilities, and assembly methodologies. All activities will adhere to regulatory requirements and the company's Quality Management System (QMS).
CONTRACT DETAILS:
This is a contract-to-hire opportunity anticipated to require 40 hours per week. Candidates should be based in the local area and available for on-site work throughout the week.
QUALIFICATIONS:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- A minimum of 5 years of experience within the Medical Device sector.
- Proficiency in SolidWorks or other CAD software.
- Experience with quality systems in compliance with US FDA Quality System Regulation (cGMP) and ISO 9001 / EN 46001 / ISO 13485 standards.
- Preferred experience in ISO Class 7 Clean Room environments.
- Familiarity with Class I, II, and III medical devices is advantageous.
- Knowledge of Statistical Process Control principles is preferred.
- Experience in polymer extrusion or thermoplastic processing is a plus.
- Prior involvement with internal or external quality system audits in the medical device industry is preferred.
This position is managed by Jamie Zogaric.
