Manufacturing Engineer 3

San Diego, CA, United States

Job Summary

Hologic seeks a Manufacturing Engineer 3 to optimize manufacturing processes through equipment acquisition, installation, and qualification. This role is critical in ensuring efficient, compliant, and high-quality production.

Essential Duties and Responsibilities

• Lead the design, procurement, installation, and commissioning of mechanical and electrical equipment to support manufacturing operations.

• Execute process transfers, providing comprehensive training on equipment and procedures.

• Deliver technical support for equipment maintenance, troubleshooting, and modification.

• Collaborate with equipment mechanics to optimize equipment performance.

• Develop and maintain equipment maintenance procedures.

• Manage external vendors for equipment installation, qualification, and ongoing support.

• Author and review operational procedures, documentation, and reports.

• Conduct equipment, process, and product performance testing.

• Oversee raw material and vendor qualification, and lead investigations for non-conformances.

• Contribute to QS validation efforts for new equipment and processes.

• Develop and execute IQ/OQ/PQ validation protocols and reports.

• Review and approve calibration data.

Qualifications

• Bachelor's degree in Engineering or related field

• 3-5 years of manufacturing engineering experience in a regulated industry (medical device preferred)

• Proven expertise in industrial controllers, PLCs, and manufacturing automation systems

• In-depth knowledge of CGMPs, ISO 13485, and FDA 21 CFR 820

• Proficiency in SolidWorks or Pro/E for 3D modeling

• Strong analytical skills with proficiency in statistical software (Minitab or equivalent)

• Excellent problem-solving and troubleshooting abilities

• Strong written and verbal communication skills

The annualized base salary range for this role is $93,600 to $135,400 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.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

#LI-JS1 #senior-level