Job DescriptionManufacturing Engineer II to provide engineering support for manufacturing equipment, processes, and operations. This role is responsible for supporting the evaluation, purchase, installation, qualification, and ongoing sustainment of new and existing manufacturing equipment and processes.
The Manufacturing Engineer II will troubleshoot and improve equipment and processes, support manufacturing teams, develop and update procedures, perform testing, and support process transfers from Engineering to Manufacturing. This position will also contribute to equipment and process validation activities, including Installation Qualification, Operational Qualification, and Performance Qualification documentation, execution, and reporting.
Key responsibilities include:
- Provide engineering support for troubleshooting and modifying manufacturing equipment and processes
- Support equipment mechanics, technicians, and manufacturing leads
- Create and revise equipment maintenance procedures
- Write and review operating procedures, technical documents, and reports
- Perform equipment, process, and product performance testing
- Support process transfers from Engineering to Manufacturing, including process and equipment training
- Support equipment Installation Qualification, Operational Qualification, and Performance Qualification validations
- Review and approve calibration datasheets, work orders, preventive maintenance records, and change controls
- Provide Quality System validation input and support for new equipment and process validations
- Write, execute, and summarize validation protocols and final reports
Qualifications
- Working knowledge of microprocessor controls, utility distribution systems, and process engineering
- Basic knowledge of manufacturing automation systems and best design practices
- Knowledge of CGMPs, ISO 13485, and FDA 21 CFR Part 820
- Working knowledge of Windows-based programs
- Experience with SolidWorks or Pro/E, including 3D modeling
- Proficiency with Microsoft Office and Microsoft Project
- Ability to troubleshoot equipment and process issues in a manufacturing environment
- Strong documentation, technical writing, and cross-functional collaboration skills
Education and Experience
- Bachelor's degree required
- Minimum of 2-4 years of related industry experience
- Lean and Six Sigma certification preferred but not required
The annualized base salary range for this role is $71,000 to $100,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency And Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
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