Manufacturing Engineer II
SIM SurgicalHighlight
Summary
About the Role
About You
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- 3–7 years of experience in a manufacturing engineering role, preferably in a medical device or regulated industry.
- Strong understanding of machining processes (CNC, EDM, milling, turning) and shop floor troubleshooting.
- Proficiency in SolidWorks or equivalent CAD software.
- Demonstrated experience with Manufacturing NPD, DFM principles, GD&T, and reading complex prints and models.
- Working knowledge of quality systems, ISO 13485, and FDA regulations, 21 CFR 820.
- Hands-on experience with process validations, risk analysis (PFMEA), and statistical methods (DOE).
- Strong analytical skills and problem-solving abilities.
- Clear verbal and written communication skills.
- Additive manufacturing experience.
- Proficiency with Microsoft Office and familiarity with ERP or PLM systems.
Founded in 1968 and located in Fenton, Missouri, SIM Surgical has emerged as a leading provider of contract manufacturing solutions to customers in search of the best medical device manufacturers. SIM Surgical was built on a new business model for contract-manufacturing – one based on hand craftsmanship and innovation supported by production processes designed to move your instruments or devices from concept to volume production in a fast and cost effective manner. As part of our dedication to product quality, processes, and delivery, we take pride in our equipment and the capabilities which that equipment provides. We maintain world class machining centers to manufacture a broad variety of surgical instruments and implants. Our facility houses all departments in one site for quick and convenient contact within our organization. We serve the following specialty markets: • Arthroscopy • Spine • Interventional spine • Trauma • Small joint • Large joint • Dental • Extremities • Opthalmic