Sr. Mechanical Engineer

Hologic•Newark, NJ

33d

About The Position

The Sr. Mechanical Engineer supports on-market breast and skeletal health products throughout their commercial lifecycle. This role leads and supports end-of-life (EOL) component and material replacements, non-conformance event (NCE) dispositions, corrective and preventive actions (CAPAs), supplier quality issues, manufacturing issues, and complaint investigations. The Sr. Mechanical Engineer will conduct root cause analysis on field and manufacturing issues and translates findings into robust, verifiable engineering changes. Partners with Supplier Quality Engineering, Manufacturing Engineering, Quality, Regulatory, and Complaint Handling to resolve issues affecting product availability, quality, and performance. Balances technical rigor with the urgency of sustaining work — keeping on-market products supplied, compliant, and performing as intended — while maintaining full design history and documentation traceability. Works on problems of diverse scope where analysis of data requires evaluation of varying factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Provides instruction and mentorship to newer engineers.

Requirements

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

Nice To Haves

Experience in medical device design
Functional understanding Geometric Dimensioning and Tolerancing (GD&T)
Strong understanding of mechanical design and analysis.
Excellent analytical, problem-solving, and troubleshooting skills.
Ability to drive alignment, make trade-off decisions, and manage ambiguity.
Organized, detail-oriented, and able to manage multiple priorities in parallel.

Responsibilities

Represents Sustaining Engineering and department culture through example, leadership and excellent communication skills.
Leads and/or supports product investigations for field complaints, non-conformances, and manufacturing issues, applying structured root cause analysis methodologies (e.g., 5-Why, Fishbone, FMEA) to identify and verify true root cause.
Owns or supports engineering activities for CAPAs, including investigation, containment, corrective action definition, implementation, and effectiveness checks.
Manages end-of-life (EOL) component, material, and supplier changes, including identification and qualification of alternate/cross parts, obsolescence risk assessment, and lifecycle planning.
Partners with Supplier Quality Engineering (SQE) to resolve supplier-driven quality issues, including supplier corrective action requests (SCARs), incoming inspection discrepancies, and first article inspection (FAI) dispositions.
Investigates manufacturing issues and non-conformances (NCEs) on the production floor; collaborates with Manufacturing and Operations to define containment, disposition, and permanent corrective actions.
Supports complaint investigations in partnership with Complaint Handling and Post-Market Surveillance, providing technical analysis and engineering rationale for complaint dispositions.
Authors, executes, and reviews engineering change orders (ECOs), validation/verification protocols and reports, and supporting documentation for sustaining changes, maintaining project and documentation control.
Performs design and mechanical analysis to assess the impact of proposed changes on form, fit, function, reliability, manufacturability, and serviceability.
Creates schedules, monitors progress and status of all assigned investigations and projects, and reports progress and problems to management or project teams on a timely basis.
Uses computer-assisted engineering tools (CAD/CAE, GD&T) to evaluate proposed mechanical changes and document engineering rationale.
Manages multiple concurrent investigations and sustaining projects, prioritizing based on product risk, customer impact, and compliance timelines.