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Mechanical Engineering Senior

Hologic Inc

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. 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. Works on problems of diverse scope where analysis of data requires evaluation of varying factors. resolves a wide range of issues in creative ways. 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., 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.Required QualificationsBachelor’s degree in Mechanical Engineering5+ years in a relevant role.Preferred QualificationsExperience in medical device designFunctional understanding Geometric Dimensioning and Tolerancing (GD&T)Key Skills and CompetenciesStrong understanding of mechanical design and analysis.For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and an annual bonus scheme, one of our talent partners can discuss this in more detail with you.The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.#

Vacancy posted 4 days ago
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