R&D Technician 3, V&V

Teleflex•Maple Grove, MN

About The Position

The Verification and Validation Technician 3 coordinates studies and leads assigned support technicians in generating data for R&D processes. The role calls for high technical expertise, tactical problem-solving, and ownership of selected laboratory processes. The technician influences product development and sustaining projects and provides leadership to other technicians. The position coordinates and performs verification and validation testing and related laboratory activities, including accelerated and real-time aging, OQ/PQ, conditioning and packaging testing, test-article handling, and coordination with external services. It supports the generation of accurate, repeatable data, maintains laboratory documentation and calibration programs, and contributes to investigations and method qualification or validation. When assigned, the role also performs initial statistical analysis and method-validation studies in collaboration with engineering team members.

Requirements

High school diploma or GED required.
Four years of related experience required with a preferred two-year technical degree; seven years of related experience required without a degree.
Ability to manage a dynamic workload and efficiently prioritize small and large tasks.
Working knowledge and experience implementing Good Documentation Practices (GDP).
Experience with and working knowledge of ISO 13485 and FDA requirements.
Experience with IQ, OQ, and PQ validation, and DV and TMV testing of medical devices.
Attention to detail and ability to manipulate small physical items carefully and precisely to generate consistent output.
High mechanical aptitude and strong problem-solving and decision-making skills, including critical thinking and identifying potential solutions.
Computer literacy.

Nice To Haves

Two-year technical degree in a scientific discipline.

Responsibilities

Create, review, and provide feedback on test procedures to ensure they are consistently executable and trainable.
Train others on test methods in accordance with SOP requirements, including test procedures, setup, part preparation, and calculations, and verify their understanding and capability.
Own key V&V deliverables for assigned study execution and data generation.
Perform verification and validation product tests, accelerated aging, real-time aging, and OQ/PQ according to test procedures and protocols, generating accurate and repeatable data.
Coordinate tests to meet project deadlines and communicate status to the lab manager.
Coordinate conditioning and packaging testing and reporting, including vendor communications.
Repackage and archive test articles after testing.
Assist in investigating non-conformances and contribute to root-cause investigations for failures.
Maintain GLP/GMP documentation practices.
Coordinate shipping and receiving of test articles.
Maintain laboratory calibration and qualification programs.
Coordinate tests with external services.
Coordinate inventory of laboratory materials and consumables.
Assist with qualification and validation of new test methods.
When assigned, perform initial data analysis using Minitab 6 pack or similar to identify data concerns for escalation to more detailed analysis.
Perform GRR, Attribute Agreement, and IMR-based test method validations with support from engineering team members.