Lead Sustaining Mechanical Engineer, Medical Devices

Hologic, Inc.; Town of Newark (WI); Sur place; USD 98 000 - 153 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Résumé du poste

Hologic, Inc. seeks a Sr. Mechanical Engineer to support on-market breast and skeletal health products across their lifecycle.

You will lead end-of-life changes, CAPAs, supplier quality issues, and complaint investigations, performing root cause analysis to drive robust engineering changes. Collaborating with SQE, Manufacturing, Quality, Regulatory, and Complaint Handling, you will ensure product availability, compliance, and traceability while mentoring junior engineers and guiding ECOs,

Qualifications

• Bachelor’s degree in Mechanical Engineering is required.
• 5+ years in a relevant role is required.
• Experience in medical device design is preferred.

Responsabilités

• Lead and support product investigations for field complaints, non-conformances, and manufacturing issues using structured root cause analysis.
• Apply methods such as 5-Why, Fishbone, and FMEA to identify true root cause.
• Own or support CAPAs, including containment, corrective actions, and effectiveness checks.
• Manage end-of-life component, material, and supplier changes with lifecycle planning.
• Collaborate with SQE to resolve supplier quality issues and dispositions.
• Investigate manufacturing issues and NCEs with Manufacturing to define containment and permanent corrective actions.
• Support complaint investigations with technical analysis for dispositions.
• Author and review ECOs, validation protocols, and documentation for sustaining changes.
• Perform design/ mechanical analysis to assess impact of changes on form, fit, function, reliability, manufacturability and serviceability.
• Create schedules and monitor progress of investigations and projects.

Connaissances

Analytical problem solving

Mechanical design analysis

Project prioritization

Communication

Formation

Bachelor’s degree in Mechanical Engineering

Outils

CAD/CAE

GD&T

Description du poste

Hologic, Inc. seeks a Sr. Mechanical Engineer to support on-market breast and skeletal health products across their lifecycle.

You will lead end-of-life changes, CAPAs, supplier quality issues, and complaint investigations, performing root cause analysis to drive robust engineering changes. Collaborating with SQE, Manufacturing, Quality, Regulatory, and Complaint Handling, you will ensure product availability, compliance, and traceability while mentoring junior engineers and guiding ECOs,