R&D Technician 3, V&V

Teleflex; Maple Grove (MN); On-site; USD 66,000 - 99,000; Full time

Job summary

Teleflex Incorporated in Maple Grove, MN is seeking a Verification and Validation Technician 3 to coordinate studies and lead support technicians in data generation for R&D.

This role requires high technical expertise, training in test methods, and ownership of lab processes, influencing product development and sustaining projects while ensuring quality and compliance in GLP/GMP practices.

Qualifications

• High school diploma or GED required.
• Prefer 2-year technical degree in a scientific discipline.
• Minimum 4 years of related experience; without degree, 7 years may suffice.

Responsibilities

• Create, review and provide feedback on test procedures to ensure they are executable and trainable.
• Train others on test methods per SOP requirements and ensure understanding of procedures.
• Own key V&V deliverables for assigned study execution and data generation.
• Coordinate tests to meet deadlines and communicate status to lab manager.
• Coordinate Conditioning and Packaging testing and reporting; manage vendor communications.
• Repackage and archive test articles post testing.
• Assist in investigation of non-conformances and root-cause analysis.
• Maintain GLP/GMP documentation practices.
• Coordinate shipping/receiving of test articles; maintain calibration programs.
• Coordinate tests with external services; manage lab inventory.
• Assist in qualification/validation of new test methods.

Skills

GDP knowledge

ISO13485 & FDA

IQ/OQ/PQ validation

Attention to detail

Mechanical aptitude

Problem solving

Computer literacy

Dynamic workload management

Education

HS diploma/GED

2-year technical degree

4 years related experience

Without degree: 7 years experience

Job description

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Expected Travel

Up to 10%

Requisition ID

14672

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Interventional – The Interventional business unit at Teleflex develops innovative medical devices used to diagnose and treat coronary and peripheral vascular diseases. We focus strategically on coronary and peripheral interventions, vascular and bone access, and large-bore closure solutions.

Our portfolio includes a broad range of clinically relevant products, such as the GuideLiner™ and Turnpike™ Catheters; the Orsiro™ Mission™ Drug-Eluting Stent; the PK Papyrus™ Covered Coronary Stent; the Ringer™ Perfusion Balloon Catheter; the Pulsar™ -18 T3 Self-Expanding Stent; Passeo™ Balloon Catheters; and the OnControl™ Powered Bone Access System.

Backed by a strong R&D pipeline, our rapidly growing Interventional business unit is well positioned to continue advancing new technologies that support the treatment of critically ill patients. Join a dynamic team dedicated to delivering innovative medical solutions that make a meaningful difference in patients’ lives.

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

• 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

• 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.
• 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.
• 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.

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.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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