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Equipment and Automation Engineer 2
ICONMA, LLC
- 🇺🇸 United States
- On-site
- 23 hours ago
- $34.04 – $37.08 / hour
- GD&T
- Vault
- GMP
- SolidWorks
23 hours ago
Responsibilities:
- Create Solid works designs and drawing files for new and existing products.
- Create Assembly files with complete Bill of Materials.
- Create Drawing files using correct tolerances, including GD&T.
- Support the PLM Vault system and product lifecycle management requirements.
- Help develop and create assembly procedures for new or modified designs.
- Work with external vendors to have prototype parts quoted and ordered as needed
- Support the assembly, testing, and documentation of designs.
- Lead or support Design Reviews, First Article Inspection Reports, and non-conformance investigations as needed.
- Support the part and assembly documentation requirements for the manufacturing and quality systems in accordance with FDA, GMP, ISO, CAP, CLIA requirements.
- Apply defined procedures to execute and document changes to existing equipment.
- Create, document, and execute protocols to support process or part changes.
- Investigate problems, gather facts, analyze data, and draw accurate conclusions.
- Troubleshoot and repair equipment.
- Support failure analysis investigations, identify root cause analysis with support from more experienced team members, and develop solutions to resolve quality issues.
- Support the building and testing of custom equipment.
- Provide manufacturing support for the repair center.
- Apply technical knowledge to identify opportunities and recommend improvements to existing equipment and processes.
- Develop implementation plans and execute assigned tasks.
- Lead less complex improvement projects.
- Manage time and competing priorities with minimal guidance from leadership.
- Communicate project status and resource needs; prepare and present reports.
- Follow procedures and maintain detailed records in accordance with FDA, ISO, CAP, CLIA requirements.
- Ability to work independently and as part of a team within a matrix organization.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Ability to work designated schedule.
- Ability to lift up to 50 pounds as needed
- Ability to work in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
- Ability to comply with all applicable personal protective equipment requirements.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in Engineering with 2+ years of experience; or, in lieu of Bachelor's degree, Associates degree in Engineering, Technology, Electronics, or similar field with 4+ years of experience.
- Prior experience with Solidworks designs, drawing creation and BOM managment.
- Demonstrated ability to drive project to successful completion.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Preferred Qualifications
- 2+ years of experience in engineering or relevant life sciences / medical device industry.
- 2+ years of experience working in manufacturing or engineering environments applying problem solving skills and process improvements.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Equipment and Automation Engineer 2 · ICONMA, LLC