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Mechanical Engineer II

Location: Roseville, MN

Resuscitation

Overview

As a Mechanical Engineer II on our Resuscitation R&D team, you will execute the design of parts and assemblies for new and revised Intrathoracic Pressure Regulation (IPR) Therapy products or sub-systems. You will also collaborate with a cross-functional team of engineers and scientists in support of ingress protection, flow/pneumatics, shock/vibration control, EMI isolation, and thermal management per defined product goals and requirements. The team member is also expected to apply good design practices, procedures, and design criteria in the development of assemblies, parts, and subsystems.

 

  • Layout and develop new assembly and part designs.  Complete engineering mechanics analysis, thermal/flow analysis, and tolerance analysis.
  • Create detailed design documentation of new and revised products including part drawings, assembly documents, Bills of Materials, and purchasing specifications.
  • Create Engineering Change Orders to enable control and release of designs to production under the ZOLL Quality System.  
  • Support document preparation for test and regulatory submission of new/existing designs.  
  • Support development of risk assessments and design/process FMEA for creation of the design history file.
  • Lead and participate in technical design reviews for new or revised products and other projects as assigned.
  • Lead or support troubleshooting activities, investigate the root cause to a successful conclusion, and help to resolve product complaints and CAPAs.
  • Present new designs to suppliers and evaluate samples and prototypes for build and test.
  • Develop test plans, DOEs and validation IQ/OQ/PQ protocols.
  • Conduct part, subsystem, and system verification and validation testing of new designs complete with supporting documentation.
  • Technical report writing, statistical analysis, and data evaluation.
  • Conduct design of experiments and laboratory testing of new and legacy products and document results.
  • Support management activity in preparation and maintenance of schedule, budget and project reporting.

Responsibilities

 

  • Proficiency with SolidWorks including Part Design and Detailed Drawings (PDM and Simulation a plus).
  • Working knowledge of drawing creation per ASME Y 14.5 2009.
  • Ability to design, document and analyze parts encountered in packaging of embedded systems (such as molded plastic housings, sheet metal, gaskets, PCBs, LCDs, cables and labels).
  • Strong written and verbal communication skills.
  • Ability to work with minimal oversight, i.e. “self-motivated.”
  • A demonstrated commitment to continuous improvement of job related skills.

Qualifications

 

  • Bachelor of Science in Mechanical Engineering.
  • 3 to 5 years of Mechanical engineering and product design experience.
  • SolidWorks CSWP preferred.
  • Experience in medical or other highly regulated industry is strongly desired.
  • Working knowledge of IEC 60601, FDA, GMP, ISO 13485:2003 are all a plus.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of

activities, duties, or responsibilities that are required of the employee for this job.  Duties,

responsibilities, and activities will be reviewed periodically as duties and responsibilities change

with business necessity.  Essential and marginal job functions are subject to modification.

 

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V.