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Validation Engineer
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Validation Engineer

Job Description

We are seeking a Validation Engineer for a very important client.

Job Duties : Provides technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems.

POSITION DESCRIPTION:

The Reliability Test Method Validation (TMV) Engineer will support released Atrial Fibrillation (AF) Ablation medical devices and systems throughout the product life cycle with a particular focus on validating existing test methods by evaluating them for suitability and clinical relevance. Work to resolve testing issues by collaborating with cross functional team. The Reliability Engineer will work closely with Continuation/Sustaining Engineering, Product Development, Manufacturing Operations, Post Market and Operations Quality to plan, execute and complete test method validation protocols and reports. The position will include travel to Carlsbad, California and Montreal, Canada. CRDM, AF Solutions seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.

POSITION RESPONSIBILITIES:

Starting with test method validation assessment documentation, candidate will develop a plan to complete validation activities of existing test methods and then execute on the plan. Review design and process changes and assess impact to assure reliability requirements are met. Complete Gage R&R studies on test methods used for design verification, receiving inspection, in process checks (mfg), final QC checks (mfg) and returned products analysis. Complete statistical analysis using Minitab on test data gathered. Working with design and/or process expert, use reliability testing and statistical methods and concepts to gather evidence of test method validation. Provide updates to management on status of overall test method validation project plan.

Job Requirements

The ideal candidate will need the following:

BASIC QUALIFICATIONS:

EDUCATION REQUIRED:

-Bachelor’s degree in Engineering

YEARS OF EXPERIENCE

-2+ years of experience in the design, qualification and manufacture of medical devices; Experience with validation of test methods. Reliability, Design Assurance, design verification and validation testing, product development, reliability or advanced manufacturing/process development engineering functions.

-Experience writing test protocols and reports. Experience with test methods. Experience with developing fixtures and basic inspection methods (tool maker scope, quadra-check, instron pull tester).

SPECIALIZED KNOWLEDGE REQUIRED

-Proficiency with data analysis using statistical techniques and reliability tools.

-Proficiency with Minitab, MS word and MS excel.

-Knowledge of Electrical Engineering or Mechanical Engineering

DESIRED/PREFERRED QUALIFICATIONS

-Demonstrated verbal and written communication skills working across geographies and departments

-Familiarity with medical device standards, processes and documentation

-Familiarity with cardiac anatomy, clinical electrophysiology experience and either surgical or catheter ablation procedures.

-Proficiency with statistical software packages, quality tools and MS applications: Matlab, Powerpoint, Excel (with ability to write macros or small analysis programs a plus).

-Able to travel 10-25% to Carlsbad, California and Montreal, Canada.

Job Snapshot

Employment Type Contractor
Job Type Engineering
Education 4 Year Degree
Experience At least 2 year(s)
Manages Others Not Specified
Relocation No
Industry Medical Equipment, Other Great Industries
Required Travel Not Specified
Job ID mdATR104341
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Validation Engineer


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