Equipment Engineer

6AM City, LLC; Minnesota; On-site; USD 90,000 - 140,000; Full time

Job summary

6AM City, LLC is seeking an Equipment Engineer II to evaluate, select, and support manufacturing equipment for safe, reliable production. You will oversee installation, validation, maintenance, and continuous improvement across the equipment lifecycle.

The role requires experience with IQ/OQ/PQ validation, equipment maintenance, and change control in a regulated environment, with a focus on improving uptime and process efficiency.

Qualifications

• Bachelor’s degree in engineering or equivalent; minimum 2 years of relevant experience with a bachelor’s degree.
• Experience with equipment validation lifecycle (IQ/OQ/PQ) and process validation.
• Experience in regulated manufacturing environments, preferably medical devices.

Responsibilities

• Evaluate, select, and order manufacturing equipment cost-effectively.
• Oversee installation, modification, upgrades, and maintenance of equipment.
• Maintain records of manufacturers’ notices, upgrades, and safety issues.
• Study equipment performance to increase uptime and resolve issues.
• Provide technical support to repair teams and process engineering.
• Define and maintain preventative maintenance schedules.
• Contribute to projects advancing new technology and therapies.
• Coordinate projects with stakeholders to meet milestones.
• Suggest system or process enhancements to improve efficiency.
• Communicate status and needs to internal contacts; mentor junior staff.
• Apply IQ practices and support validation lifecycle (IQ/OQ/PQ).
• Support computer and software validation for equipment systems.
• Participate in change control for medical devices.

Skills

Equipment engineering

Preventive maintenance planning

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Software validation

Change control

Analytical/problem-solving

Effective communication

Education

Bachelor’s degree in engineering

Advanced degree (optional)

Tools

IQ/OQ/PQ validation tools

Validation software

Job description

Job Description

Job Title: Equipment Engineer

Job Description

The Equipment Engineer II evaluates, selects, and supports manufacturing equipment to ensure safe, reliable, and cost-effective production of company products. This role oversees the full lifecycle of manufacturing equipment, from selection and installation through validation, maintenance, and continuous improvement. As a technical specialist, the engineer contributes to research and development initiatives, supports process engineering and repair teams, and helps introduce or advance technologies and therapies while adhering to established policies and quality standards.

Responsibilities

• Evaluate, select, and order manufacturing equipment that is appropriate and cost-effective for producing company products.
• Oversee the installation, modification, upgrade, and maintenance of manufacturing equipment, ensuring compliance with internal procedures and regulatory expectations.
• Maintain current and accurate records of equipment manufacturers’ technical notices, upgrades, and safety issues, and ensure that relevant updates are implemented.
• Study equipment performance to identify opportunities to increase uptime and resolve equipment-related problems that affect the manufacturing process.
• Provide technical support to manufacturing equipment repair teams and process engineering organizations to troubleshoot issues and improve equipment performance.
• Define, write, and maintain preventative maintenance schedules to maximize equipment reliability and minimize unplanned downtime.
• Contribute as an individual technical specialist to projects that advance existing technology or introduce new technology and therapies, from design through implementation.
• Formulate, deliver, and manage assigned projects, coordinating with stakeholders to achieve defined objectives and project milestones.
• Recommend enhancements to systems, processes, or equipment to solve problems and improve the effectiveness and efficiency of the job area.
• Communicate regularly with internal contacts to share information, report status, and discuss needs and issues that support informed decision-making.
• Participate in cross-functional assignments as needed, collaborating with other functions to support broader organizational goals.
• Provide guidance and assistance to entry-level professionals or support staff in related technical areas, acting as a mentor when appropriate.
• Apply equipment IQ (Installation Qualification) practices and support the full process validation lifecycle, including process characterization, Operational Qualification (OQ), and Performance Qualification (PQ).
• Support computer and software validation activities associated with manufacturing equipment and related systems.
• Participate in change control processes for medical devices, ensuring that equipment and process changes are properly assessed, documented, and implemented.

Essential Skills

• Practical knowledge and demonstrated competence in equipment engineering and maintenance within a manufacturing environment.
• Experience in equipment maintenance, including troubleshooting, repair support, and preventive maintenance planning.
• Experience in equipment Installation Qualification (IQ) for manufacturing systems.
• Experience with the process validation lifecycle, including process characterization, Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience with computer and software validation related to manufacturing equipment and associated systems.
• Experience with change control processes in a medical device environment.
• Ability to work independently with general supervision on moderately complex projects and assignments.
• Strong analytical and problem-solving skills, with the ability to assess equipment performance and recommend improvements.
• Effective communication skills for collaborating with internal stakeholders and sharing technical information.
• Bachelor’s degree (Baccalaureate) or, for degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Minimum of 2 years of relevant experience with a bachelor’s degree, or an advanced degree with 0 years of experience.

Additional Skills & Qualifications

• Experience working as an equipment engineer in a regulated manufacturing environment, preferably involving medical devices or similar products.
• Familiarity with preventive maintenance program development and documentation.
• Experience to contribute to research and development initiatives related to new techn