POSITION TITLE--Senior Test Engineer--Medical Devices
SALARY-OPEN-OUR CLIENT PREFERS WE DON'T POST SALARY INFO PUBLICLY BUT IF INTERESTED PLEASE APPLY AND WE WILL SHARE SALARY INFO DIRECTLY WITH YOU
The primary responsibilities of this role, Senior Test Engineer, are to:
Be responsible for analysis of test system requirements to determine scope of required verification and/ or validation activities
Be responsible for the development and implementation of verification/validation strategy, protocols and reports
Collaborate with Electrical and Software engineers in the Test Engineering group to determine appropriate verification and/or validation methodology for test system hardware and software
Review and provide input to ensure design and other documentation for test systems are complete and accurate
Author and execute IQ protocols ensuring tests systems are properly installed or updated in production
Ensure software and test systems used in manufacturing and processes adhere to quality system
Prioritize projects risks and tasks based on alignment with business needs which could change based on external factors
Provide input to evaluate, resolve, and lead cross functional communications on a broad range of technical issues impacting the production site
Engage with and resolve moderately complex challenges constrained by regulated processes using interdisciplinary skills
Support Validation Risk Assessments, Validation Master Plan development as well as Test Method Validation, Software Validation, and Process Validation execution across multiple areas
Provide advice and mentoring to less experienced engineers or technicians
Make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems
Build partnerships and work collaboratively with others to meet shared objectives
Build strong customer relationships and deliver customer-centric solutions
Ensure accountability and consistently achieve results, even under tough circumstances.
At least four years or practical work experience
At least two years of experience in verification/validation testing (Test Systems and/or Software Validation in a regulated environment)
Working knowledge of software language / platform including Net (C#), C++, Lab view, and Teststand
Proven ability to work collaboratively in a cross-functional manufacturing environment
Strong communication and interpersonal skills with ability to work well in fast-paced environment
Demonstrate skill in both analysis of complex problems and synthesis of solutions
Working knowledge and proven skills on PC including Microsoft office applications (Outlook, Word, Excel, and PowerPoint) and MS Project.
Bachelor’s degree in Engineering or Science
Direct experience within the medical device industry (FDA Regulated) and ISO 13485, ISO 62304
Project management experience.
KP RECRUITING GROUP
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.
In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.
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