Equipment Engineer II
Overview
The Equipment Engineer II evaluates selects and supports manufacturing equipment to ensure safe reliable and cost-effective production. This role oversees the full lifecycle of manufacturing equipment from selection installation 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.
What You'll Do12
- 1Evaluate select and order manufacturing equipment appropriate and cost-effective for producing company products
- 2Oversee installation modification upgrade and maintenance of manufacturing equipment ensuring compliance with internal procedures and regulatory expectations
- 3Maintain current records of equipment manufacturers technical notices upgrades and safety issues and implement relevant updates
- 4Study equipment performance to identify opportunities to increase uptime and resolve problems affecting the manufacturing process
- 5Provide technical support to repair teams and process engineering organizations to troubleshoot issues and improve performance
- 6Define write and maintain preventative maintenance schedules to maximize reliability and minimize unplanned downtime
- 7Contribute as an individual technical specialist to projects advancing existing technology or introducing new technology and therapies from design through implementation
- 8Formulate deliver and manage assigned projects coordinating with stakeholders to achieve defined objectives and milestones
- 9Recommend enhancements to systems processes or equipment to solve problems and improve effectiveness and efficiency
- 10Communicate regularly with internal contacts to share information report status and discuss needs and issues supporting informed decision-making
- 11Participate in cross-functional assignments collaborating with other functions to support broader organizational goals
- 12Guide entry-level professionals or support staff providing mentorship when appropriate
Requirements15
- 1Practical knowledge and demonstrated competence in equipment engineering and maintenance within a manufacturing environment
- 2Experience in equipment maintenance including troubleshooting repair support and preventive maintenance planning
- 3Experience with Equipment Installation Qualification IQ for manufacturing systems
- 4Experience with process validation lifecycle including process characterization Operational Qualification OQ and Performance Qualification PQ
- 5Experience with computer and software validation related to manufacturing equipment and associated systems
- 6Experience with change control processes in a medical device environment
- 7Minimum of 2 years of relevant experience with a bachelor’s degree or an advanced degree satisfying 8 CFR § 214.2(h)(4)(iii)(A)
- 8Ability to work independently with moderate supervision on complex projects and assignments
- 9Strong analytical and problem-solving skills with the ability to assess equipment performance and recommend improvements
- 10Effective communication skills for collaborating with internal stakeholders and sharing technical information
- 11Experience working as an equipment engineer in a regulated manufacturing environment preferably involving medical devices or similar products
- 12Familiarity with preventive maintenance program development and documentation
- 13Capability to contribute to research and development initiatives related to new technologies or therapies
- 14Experience mentoring or providing guidance to entry-level professionals or technical support staff
- 15Comfort working on cross-functional assignments and collaborating with diverse technical and operational teams
Salary Insight
$30 - $60k per year
Location
Required Skills
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