R&D Technician 3, V&V

Position Summary

The Verification and Validation Technician 3 coordinates studies, leading assigned support technicians to generate data in support of R&D processes.  
This role involves high levels of technical expertise, participation in tactical problem-solving, and ownership of certain lab processes.  The V&V Technician 3 will influence the course of product development and sustaining projects and provide leadership for other technicians.

Principal Responsibilities

    V&V Leadership:
•    Create, review and provide feedback on test procedures to ensure they will be consistently executable and trainable.  
•    Train others on test methods per SOP requirements, ensuring others understand all portions of test procedures and any needed setup, part preparation or calculations, and ensure their understanding and capability.
•    Serve as the accountable owner for key V&V deliverables for assigned study execution and data generation.  Perform Verification/Validation product tests, accelerated aging, real time aging and OQ/PQ per test procedures and protocols in support of R&D activities with attention to quality and detail to generate accurate, repeatable data.
•    Coordinate tests to meet the required deadlines for all projects and communicate status to lab manager 
•    Coordinate Conditioning and Packaging testing and reporting, and vendor communications
•    Repackage and archive test articles post testing in support of R&D activities
•    Assist in investigation of non-conformances and contribute to root cause investigation for failures
•    Maintain GLP/GMP documentation practices
•    Coordinate shipping and receiving of test articles in support of R&D activities
•    Maintain calibration and qualification programs within the laboratory
•    Coordinate tests with external services in support of R&D activities
•    Coordinate inventory of materials and consumables for the laboratory
•    Assist in the qualification/validation of new test methods in support of R&D activities

    Statistical and Problem-Solving Expertise:
•    When assigned in order to expedite a study, perform initial data analysis using Minitab 6 pack or similar to identify any concerns in data that should be escalated to more detailed analysis.
•    Perform GRR, Attribute Agreement, and IMR based test method validations with support from engineering team members.

Education / Experience Requirements

•    High school diploma/GED required 
•    2 year technical degree in a scientific discipline preferred
•    4 years of related experience required with the preferred degree. Without a degree, 7 years of related experience is required

Specialized Skills / Other Requirements

•    Ability to manage dynamic workload and prioritize small and large tasks efficiently.
•    Working knowledge and experience implementing Good Documentation Practices (GDP).
•    Experience with and working knowledge of ISO13485 & FDA requirements.
•    Experience with IQ, OQ, and PQ validation, DV and TMV testing of medical devices 
•    Attention to detail. Ability to manipulate small physical items with care and precision to generate consistent output.
•    High mechacial aptitude and strong problem solving/decision-making skills. Ability to think criticaly and identify potential solutions.
•    Computer literacy required.

COMPETENCIES: - incumbent must have proven abiilty to:
o    Instills Trust - Gains the confidence and trust of others through honesty, integrity, and authenticity. Follows through on commitments; is seen as direct and truthful; keeps confidences; practices what he/she teaches; shows consistency between words and actions.
o    Courage - Steps up to address difficult issues, saying what needs to be said. Readily tackles tough assignments; faces difficult issues and supports others who do the same; provides direct and actionable feedback; is willing to champion an idea or position despite dissent or political risk.
o    Optimizes Work Processes - Knows the most effective and efficient processes to get things done, with a focus on continuous improvement. Identifies and creates the processes necessary to get work done; separates and combines activities into efficient workflow; designs processes and procedures that allow managing from a distance; seeks ways to improve processes, from small tweaks to complete reengineering.

#LI-NR1

Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($65,700-$98,600)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.