R&D Technician 3, V&V

Teleflex•Maple Grove, MN

6d•$65,700 - $98,600

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 requires strong technical expertise, tactical problem-solving, and ownership of laboratory processes. The technician influences product development and sustaining projects while providing leadership to other technicians. The position executes verification and validation testing and supports R&D activities, including product tests, accelerated and real-time aging, and OQ/PQ testing. It also coordinates testing schedules, conditioning and packaging work, external services, test-article shipping and receiving, and laboratory inventory. The technician maintains laboratory calibration and qualification programs and GLP/GMP documentation, assists with non-conformance and root-cause investigations, and helps qualify or validate new test methods. When assigned, the technician performs initial data analysis using Minitab 6 Pack or a similar tool, and conducts GRR, Attribute Agreement, and IMR-based test-method validations with engineering support.

Requirements

High school diploma or GED.
Four years of related experience with a preferred two-year technical degree in a scientific discipline, or seven years of related experience 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, design verification (DV), and test method validation (TMV) testing of medical devices.
Attention to detail and ability to handle 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.
Proven ability to instill trust, act with courage, and optimize work processes.

Nice To Haves

Two-year technical degree in a scientific discipline.

Responsibilities

Create, review, and provide feedback on test procedures to ensure they can be executed consistently and used for training.
Train others on test methods in accordance with SOP requirements, including procedures, setup, part preparation, and calculations.
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 testing according to procedures and protocols.
Coordinate testing to meet project deadlines and communicate status to the lab manager.
Coordinate conditioning and packaging testing, reporting, and vendor communications.
Repackage and archive test articles after testing.
Assist with non-conformance investigations and 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 laboratory materials and consumables inventory.
Assist in qualifying and validating new test methods.
When assigned, perform initial data analysis using Minitab 6 Pack or a similar tool to identify concerns for escalation.
Perform GRR, Attribute Agreement, and IMR-based test-method validations with engineering team members.