LI
Equipment and Automation Engineer II
LanceSoft Inc
- 🇺🇸 United States
- On-site
- 2 weeks ago
- triage
- SolidWorks
- GD&T
- Vault
- GMP
2 weeks ago
Location: Madison, WI – 53719
Duration: 12 Months
Position Overview
- Our Mission at Client is to eradicate cancer and the suffering it causes – through tests that help prevent it, detection that finds it earlier, and guidance for its successful treatment. Come join our team and make a difference in other people’s lives.
- The Equipment and Automation Engineer 2 is primarily responsible for manufacturing support for new and existing equipment, and helping to launch new equipment into Production. This position will participate in a variety of engineering design functions, provide technical drawings for our suppliers and Production Teams, triage failures, and manage improvement projects. This position will work cross functionally with multiple departments to ensure that the business objectives and our customer needs are met. This is an ideal role for a hands-on Mechanical Engineer with Solidworks design experience and good communication skills looking to make an impact in the fight against cancer.
Essential Duties include but are not limited to the following:
- Create Solidworks 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.
- Regular and reliable attendance.
- Ability to work designated schedule.
- Ability to lift up to 50 pounds for< 5% of a typical working day.
- 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.
- Ability to travel approximately 10% of working time for occasional training, out of state vendor site visits, and travel between Client sites.
- Other duties as assigned.
Minimum Qualifications:
- 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.
- Authorization to work in the United States without sponsorship.
- 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.
Equipment and Automation Engineer II · LanceSoft Inc