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ZOLL Medical

Emergency care medical devices and software

Mechanical Engineer 2 - Sustaining

Design EngineeringConfirmed live in the last 24 hours
Full-timeChelmsford, MA, USA

About the Job

Requirements

  • A Bachelor of Science in Mechanical Engineering is required.
  • Three to five years of mechanical engineering and product design experience are required.
  • Ability to design, document, and analyze components used in packaging embedded systems, including molded plastic housings, sheet metal, gaskets, printed circuit boards, liquid-crystal displays, cables, and labels.
  • Proficiency with SolidWorks Part Design and Detailed Drawings is required; Product Data Management and Simulation are a plus.
  • Working knowledge of drawing creation per ASME Y14.5-2009 is required.
  • SolidWorks Certified Professional (CSWP) certification is preferred.
  • Working knowledge of IEC 60601, FDA requirements, Good Manufacturing Practice, and ISO 13485:2003 is a plus.
  • Experience in a medical or other highly regulated industry is strongly desired.
  • Ability to work with minimal oversight is required.
  • Commitment to continuous improvement of job-related skills is required.
  • Strong written and verbal communication skills are required.
  • Applicants must reside within a reasonable commuting distance of Chelmsford, Massachusetts; relocation is not offered.
  • Applicants who will need immigration-related sponsorship now or in the future are not eligible.

Responsibilities

  • Lay out and develop new assembly and part designs.
  • Complete engineering mechanics, thermal/flow, and tolerance analyses.
  • Create detailed design documentation for new and revised products, including part drawings, assembly documents, bills of materials, and purchasing specifications.
  • Create Engineering Change Orders to control and release designs to production under the ZOLL Quality System.
  • Support preparation of documents for testing and regulatory submissions for new and existing designs.
  • Support development of risk assessments and design/process failure mode and effects analyses for the design history file.
  • Lead and participate in technical design reviews for new or revised products and other assigned projects.
  • Lead or support troubleshooting, investigate root causes through resolution, and help resolve product complaints and corrective and preventive actions.
  • Present new designs to suppliers and evaluate samples and prototypes for build and testing.
  • Develop test plans, designs of experiments, and validation IQ/OQ/PQ protocols.
  • Conduct part, subsystem, and system verification and validation testing of new designs, with supporting documentation.
  • Write technical reports and perform statistical analysis and data evaluation.
  • Conduct design of experiments and laboratory testing of new and legacy products and document results.
  • Support management activities in preparing and maintaining schedules, budgets, and project reports.

Desired Qualifications

  • Experience in a medical or other highly regulated industry is strongly desired.
  • Working knowledge of IEC 60601, FDA requirements, Good Manufacturing Practice, and ISO 13485:2003 is a plus.
  • Product Data Management and SolidWorks Simulation are a plus.
  • SolidWorks Certified Professional (CSWP) certification is preferred.

About the Company

ZOLL Medical

Emergency care medical devices and software

ZOLL Medical develops and markets medical devices and software for emergency and critical care. Its products include defibrillators and automated external defibrillators (AEDs), mobile ECG systems, disposable electrodes, temperature management devices, and sleep apnea therapies, all complemented by software that integrates with the hardware to manage and analyze patient data. The products are designed for hospitals, emergency medical services (EMS), and other healthcare facilities worldwide, offering an end-to-end solution that combines hardware and data software. The goal is to improve patient outcomes and boost clinical and operational efficiency through reliable, integrated devices and data-enabled software for emergency and critical care.

Company size
1,001-5,000
Company stage
Acquired
Total funding
$2.2B
Headquarters
Chelmsford, MA
Founded
1980

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