What are the responsibilities and job description for the Biomedical Manufacturing Engineer II position at Infosoft, Inc.?
Job Title: Biomedical Manufacturing Engineer II
Pay Rate: $47.24/HR
Duration: 6 months
Location: Draper, UT (100% Onsite)
Our Client is a Global medical device Manufacturer.
We are looking for a Manufacturing Engineer II
- Develop and execute manufacturing validation activities, including IQ, OQ, and PQ protocols for manufacturing processes and equipment.
- Create and maintain inspection methods, Test Method Validation (TMV) documentation, and Quality Plans.
- Perform and analyze Gauge Repeatability & Reproducibility (GR&R) studies for approximately 200 components.
- Develop validation protocols, execute testing, analyze results, and prepare validation reports.
- Support migration of inspection methods from SmartScope to Keyence vision inspection systems.
- Work with raw material inspection and manufacturing quality activities to ensure product compliance.
- Utilize Minitab for statistical analysis, process capability studies, and validation data evaluation.
- Collaborate with cross-functional teams including Quality, Manufacturing, and Operations to implement process improvements.
- Spend approximately 30% of the time on the manufacturing floor supporting production and 70% on documentation and engineering activities.
Required Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- 2–4 years of Manufacturing Engineering or Process Validation experience in a regulated industry.
- Hands-on experience developing and executing IQ/OQ/PQ validation protocols.
- Experience creating validation documentation, inspection methods, and Test Method Validation (TMV) protocols.
- Strong experience performing GR&R studies and statistical analysis using Minitab.
- Experience with inspection equipment such as Keyence and/or SmartScope vision measurement systems.
- Knowledge of raw material inspection and manufacturing quality processes.
- Strong technical writing, documentation, and problem-solving skills.
Preferred Qualifications
- Experience in the medical device industry.
- Familiarity with FDA-regulated manufacturing environments, ISO 13485, or other highly regulated industries.
- Experience supporting manufacturing process improvements and quality initiatives.
Salary : $47