Job Title:Process Engineer
Reports To:Manufacturing Engineering Manager
Location:Vista, California
Business Unit Description:Bracing & Support
Job Title/High-Level Position Summary:The process engineer is responsible for developing and optimizing formulations, manufacturing processes, and equipment requirements from pilot to full-scale production. Collaborates cross-functionally to ensure process compatibility, evaluates test data to establish specifications, and supports implementation of new technologies and process improvements while resolving moderately complex technical issues.
Key Responsibilities:Performs various tasks which may include but are not limited to:
- Works on, and leads projects related to process improvement
- Keeps track of relevant KPI's to determine improvement opportunities
- Analyzes data to determine trends on process quality and output
- Makes use of root cause analysis tools to review and resolve process issues
- Implementation of EGX manufacturing tools and principles.
- Manufacturing process design and validation
- Creates and keeps manufacturing documentation current
- Ensures that manufacturing metrics are accurate based on time and process studies
- Interacts frequently with functional peer professionals in Operations, Quality, Supply Chain, Warehouse, Maintenance, Customer Care and Human Resources
Minimum Basic Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- BA/BS in Mechanical Engineering or relevant field of study
- Minimum 2 years of experience with CAD modeling (Solidworks)
- Minimum 2 years of experience with GMP and QMS documentation
Travel Requirements: May require travel up to 5%
Desired Characteristics:- Very hands on engineer
- Knowledgeable with SPC
- Knowledgeable with FDA regulation (21 CFR 820) and ISO 13485
- Experience with IQ/OQ/PQ
- Knowledge and experience with GMP and QMS documentation
Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.
We offer a comprehensive benefits package that includes:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal Services
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