Find Jobs
Make your next engineering career move with SoloPoint.
Manufacturing Engineer
Employment Type:
Direct
Category: Manufacturing Engineer
Job Number: 11043
Pay Rate: $150K/yr-$170K/yr
Job Description
Qualifications:
- Bachelor’s degree in engineering or related field
- Experience of at least 8 years in medical device manufacturing
- ISO 13485 and FDA environment
- Ability to perform root cause analysis and execute process validations (IQ, OQ, PQ)
- Understanding of statistical analysis (SPC, CPK, DOE)
- Skilled in equipment, tooling, and fixture design, testing, and implementation
- Knowledge of design tools, prototyping techniques, and process evaluation methods
- Strong analytical skills and decision-making ability
Responsibilities:
- Design and validate manufacturing processes, equipment, and fixtures for catheter production
- Troubleshoot production issues and implement improvements for operational efficiency
- Lead projects to enhance production metrics such as uptime, cycle time, and throughput
- Collaborate with vendors to select and develop equipment suitable for manufacturing needs
- Support scale-up efforts from development to commercialization, including process validation and transfer