Sustaining Mechanical Engineer: CAPA, EOL & RCA Lead

Hologic, Inc.

Newark (DE)

Hybrid

USD 98,000 - 153,000

Full time

9 days ago

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Job summary

Hologic, Inc. is seeking a Sr. Mechanical Engineer to support on-market breast and skeletal health products across the lifecycle. You will lead investigations, CAPAs, and EOL changes, partnering with SQE, Manufacturing, Quality and Regulatory to resolve issues while maintaining traceability.

You will perform root-cause analysis, apply structured methods, and mentor newer engineers. The role emphasizes sustaining product availability, compliance, and robust documentation.

Qualifications

  • Bachelor’s degree in Mechanical Engineering is required.
  • 5+ years in a relevant role required.

Responsibilities

  • Lead and/or support product investigations for field complaints, non-conformances, and manufacturing issues using structured root cause analysis.
  • Own or support CAPAs including investigation, containment, corrective action, implementation and effectiveness checks.
  • Manage end-of-life (EOL) component, material, and supplier changes with lifecycle planning and obsolescence risk assessment.
  • Partner with SQE to resolve supplier quality issues, SCARs, and FAI dispositions.
  • Investigate manufacturing issues and NCEs with Manufacturing to define containment, disposition, and permanent corrective actions.
  • Author and review ECOs, validation/verification protocols and reports, maintaining project and documentation control.

Skills

Mechanical design
Analytical skills
Problem-solving
Decision making
Prioritization

Education

Bachelor's degree in Mechanical Engineering

Tools

CAD/CAE
GD&T

Job description

Hologic, Inc. is seeking a Sr. Mechanical Engineer to support on-market breast and skeletal health products across the lifecycle. You will lead investigations, CAPAs, and EOL changes, partnering with SQE, Manufacturing, Quality and Regulatory to resolve issues while maintaining traceability.

You will perform root-cause analysis, apply structured methods, and mentor newer engineers. The role emphasizes sustaining product availability, compliance, and robust documentation.

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