Process Engineer - 2

Job Description:

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

As a key member of the Manufacturing Engineering Department, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Manufacturing Engineer - II

Reports To:

Eduardo Zepeda

Location:

VMC - Vista, CA

• Works on, and leads projects related to process improvement
• Analyzes data to determine trends on process quality and output
• Implementation of EGX manufacturing tools and principles.
• Defines equipment needs for the process and builds objective cases for investment
• Participates in NPI projects
• Manufacturing process design and validation of class II and III medical devices
• 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 .
• Gain technical process and product expertise in order to support business decisions, including but not limited to product test equipment, process cycle times, process flows and product requirements.
• Own operation's KPI's of Scrap, Yield and Productivity in pursuit of process improvements.
• Manage equipment, raw material and process validations including creation of protocols, identification of test requirements, sample size calculation, test execution, analysis and documentation of results
• Ensure documentation complies with internal procedures and external regulations for medical devices (Class I, II and III).
• Interface with R&D, Supply Chain, Production and Quality teams to coordinate successful product or raw material changes and new product or tools introduction to manufacturing.
• Lead continuous improvement activities for assigned areas. Develop and improve current process flows/methods, sourcing equipment, fixture designs and work instructions.
• Provide on-the-job training in order to increase productivity and eliminate operational waste.
• Develop or modify manufacturing process instructions and visual aids. Train others on new documents.
• Use of Root Cause Analysis tools for problem solving to reduce defects/ scrap for productivity improvement and analyze issues.
• Prepare presentations and reports, as appropriate, to communicate status of engineering projects, progress towards goals and objectives, future opportunities, and current risks/alternatives to management.

• Bachelor's Degree in Manufacturing, Mechanical or Electronical Engineer
• 1 year of prior experience with process Validation of Class II and III medical devices
• Background with electronic component manufacturing
• Proficient in computer skills and productivity software
• Knowledge of statistics and process control tools

• 10%

• Minimum of 5 years of experience in the medical industry
• Good understanding and knowledge of process validation of Class II and III Medical Devices
• Minimum 3 yrs. prior experience with process validations of Class II and III Medical devices preferred
• Drafting skills using Solidworks and/or AutoCAD
• Prior experience handling PCB's in a manufacturing environment preferred, but not required
• Strong communication and organizational skills including communicating at multiple levels in the organization.
• Ability to work in a team-oriented environment.

• 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