Equipment and Automation Engineer II

LanceSoft • Madison, WI

2d • Onsite

About The Position

The Equipment and Automation Engineer II primarily provides manufacturing support for new and existing equipment and helps launch new equipment into Production. The role performs engineering design work, creates technical drawings for suppliers and Production Teams, triages failures, and manages improvement projects. It works cross-functionally with multiple departments to meet business objectives and customer needs. The position is suited to a hands-on Mechanical Engineer with SolidWorks design experience and strong communication skills.

The engineer creates and supports designs, drawings, assembly documentation, prototypes, and equipment testing. The role also supports equipment troubleshooting and repair, failure analysis, quality investigations, and process or equipment improvements. Documentation and work must follow applicable company procedures and FDA, GMP, ISO, CAP, and CLIA requirements. The position requires occasional travel, regular attendance, and the ability to perform the listed physical and computer-based duties.

Requirements

• Bachelor’s degree in Engineering and 2 or more years of experience; alternatively, an associate degree in Engineering, Technology, Electronics, or a similar field and 4 or more years of experience.
• Prior experience with SolidWorks designs, drawing creation, and Bill of Materials management.
• Demonstrated ability to drive projects to successful completion.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the essential duties with or without accommodation.
• Ability to lift up to 50 pounds for less than 5% of a typical working day.
• Ability to work in front of a computer screen and/or type for approximately 80% of a typical working day.
• Ability to comply with applicable personal protective equipment requirements.

Nice To Haves

• Two or more years of experience in engineering or a relevant life sciences or medical device industry.
• Two or more years of experience in manufacturing or engineering environments applying problem-solving skills and process improvements.

Responsibilities

• Create SolidWorks designs and drawing files for new and existing products.
• Create assembly files with complete Bills of Materials and drawing files with 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 quote and order prototype parts as needed.
• Support design assembly, testing, and documentation.
• Lead or support design reviews, First Article Inspection Reports, and non-conformance investigations as needed.
• Support part and assembly documentation for manufacturing and quality systems in accordance with FDA, GMP, ISO, CAP, and CLIA requirements.
• Apply defined procedures to execute and document changes to existing equipment.
• Create, document, and execute protocols supporting process or part changes.
• Investigate problems by gathering facts, analyzing data, and drawing accurate conclusions.
• Troubleshoot and repair equipment.
• Support failure analysis investigations, identify root causes 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.
• 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, and prepare and present reports.
• Follow procedures and maintain detailed records in accordance with FDA, ISO, CAP, and CLIA requirements.
• Work independently and as part of a team within a matrix organization.
• Uphold company mission and values, and support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance and work the designated schedule.
• Travel approximately 10% of working time for occasional training, out-of-state vendor site visits, and travel between client sites.
• Perform other duties as assigned.

What This Job Offers

• Career Level: Mid Level