Teleflex
Sr. Principal Engineer, Verification & Validation, R&D
Teleflex, Osseo, Minnesota, United States, 55311
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 offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner™ and Turnpike™ Catheters, Ringer™ Perfusion Balloon Catheter, AC3 Optimus™ and AC3 Range™ Intra‑Aortic Balloon Pumps and the OnControl™ Powered Bone Access System. Teleflex’s product portfolio now also includes Passeo™‑18 Lux™ Peripheral Drug‑Coated Balloon Catheter, Pantera™ Lux™ Drug‑Coated Balloon Catheter, Orsiro™ Mission™ Drug‑Eluting Stent, the PK Papyrus™ Covered Coronary Stent, and more. With a strong R&D footprint and pipeline, our fast‑growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary The Sr. Principal Verification and Validation (V&V) Engineer serves as a technical authority and strategic leader across the organization. This role defines and advances V&V strategy and standards across multiple product lines, ensuring that methods, processes, and DHF deliverables drive product excellence, safety, and compliance. The Sr. Principal Engineer influences design and verification architecture, establishes new test technologies, and guides technical leaders across programs to ensure product alignment with Teleflex’s capabilities and goals.
Statistical and Problem‑Solving Expertise
Design and execute complex statistical studies, including DOE, Gage R&R, and capability analysis.
Address non‑normality and variability issues, providing actionable insights for product improvement.
Conduct test data analysis, identifying outliers, generating data plots, and interpreting statistical outputs.
Lead team in DMAIC problem solving to identify and address root cause where gaps between performance and targets exist.
V&V Leadership
Provide technical leadership across multiple product lines & define best practices and technology roadmaps.
Review and provide feedback on product specifications, user needs and design inputs to ensure requirements are verifiable/validateable and contribute to product safety and efficacy.
Own the creation of new methods for design characterization to allow selection of optimal design concepts and process technology where assigned.
Design flows of testing to optimize cost, time, and accuracy of data generated, and own submission of lab requests based on these designs.
Develop robust, statistically sound test methods, including tensile, friction force, bending, leak, simulated use, fatigue, and dimensional measurement methods, that minimize sources of variability and product risks.
Lead execution, review, and optimization of test flow design, test method training, execution, and documentation, and statistical analysis (DOE, Gage R&R, TMVs) working with engineers and technicians.
Act as accountable owner for key V&V deliverables such as Test Method Development and Validation, DV plans and protocols, statistical analysis of data, V&V reports, Statistical Sampling Requirements, and Characterization Testing.
Leadership, Mentorship, and Training
Represent Teleflex in cross BU, regulatory, or standards forums.
Provide thought leadership & guidance to support junior and mid‑level V&V Engineers, training on statistical tools, test method validation execution, and V&V best practices.
Review and approve technical documentation, reports, and protocols and provide constructive feedback; capture and disseminate lessons learned and identify & implement continuous improvement opportunities.
Train and direct technicians in performing equipment qualifications, process characterization, test method validation execution, failure investigations.
Actively contribute to team growth by developing training materials and driving continuous improvement initiatives.
Education / Experience Requirements
Bachelor’s or technical degree in related field preferred.
10+ years of engineering product development experience required.
3+ years of experience in a leadership capacity.
7+ years of experience in design and development of medical devices.
7+ years of experience in document controlled systems using PLM and ERP software; Oracle Agile/SAP preferred.
Experience and proficiency in MS Office applications (Word, Excel, Outlook, Teams, etc.).
Proficiency in Minitab or similar statistical software.
Competencies
Instill 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.
Decision Quality
– Makes good and timely decisions that keep the organization moving forward. Makes sound decisions, even in the absence of complete information.
Plans and Aligns
– Plans and prioritizes work to meet commitments aligned with organizational goals; sets objectives to align with broader organizational goals; breaks down objectives into initiatives and actions; stages activities with milestones and schedules; anticipates and adjusts contingency plans.
Cultivates Innovation
– Creates new and better ways for the organization to be successful. Comes up with useful ideas that are new, better, or unique; introduces new ways of looking at problems; can take a creative idea and put it into practice; encourages diverse thinking to promote and nurture innovation.
Optimizes Work Processes
– Knows the most effective and efficient processes to get things done, focusing 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.
Specialized Skills / Other Requirements
Prefer 15+ years in device development with sustained record of technical leadership and enterprise impact.
Excellent oral and written communication skills. Proficient at communicating effectively across functions to achieve common goals.
Ability to manage dynamic workload and prioritize small and large tasks efficiently.
Working knowledge and experience implementing Good Documentation Practices (GDP).
Advanced knowledge of technologies related to catheter testing and relevant standards, such as ISO10555, ISO80369, etc.
Experience with and working knowledge of ISO13485 & FDA requirements.
Advanced knowledge and experience with IQ, OQ, and PQ validation, DV and TMV testing of medical devices including creating supporting documentation.
Working knowledge of mechanical drawings, product requirements and engineering specifications.
Attention to detail. Ability to manipulate small pieces of data with accuracy and focus, identifying information that does not fit and implementing solutions.
High mechanical aptitude and strong problem solving/decision‑making skills. Ability to think critically and implement solutions independently.
Thorough understanding of process statistics, inspection, equipment, risk management, metrology and calibration.
The pay range for this position at commencement of employment is expected to be between $144,560.00 to $216,840; 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. If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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 Talent@Teleflex.com.
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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 offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner™ and Turnpike™ Catheters, Ringer™ Perfusion Balloon Catheter, AC3 Optimus™ and AC3 Range™ Intra‑Aortic Balloon Pumps and the OnControl™ Powered Bone Access System. Teleflex’s product portfolio now also includes Passeo™‑18 Lux™ Peripheral Drug‑Coated Balloon Catheter, Pantera™ Lux™ Drug‑Coated Balloon Catheter, Orsiro™ Mission™ Drug‑Eluting Stent, the PK Papyrus™ Covered Coronary Stent, and more. With a strong R&D footprint and pipeline, our fast‑growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary The Sr. Principal Verification and Validation (V&V) Engineer serves as a technical authority and strategic leader across the organization. This role defines and advances V&V strategy and standards across multiple product lines, ensuring that methods, processes, and DHF deliverables drive product excellence, safety, and compliance. The Sr. Principal Engineer influences design and verification architecture, establishes new test technologies, and guides technical leaders across programs to ensure product alignment with Teleflex’s capabilities and goals.
Statistical and Problem‑Solving Expertise
Design and execute complex statistical studies, including DOE, Gage R&R, and capability analysis.
Address non‑normality and variability issues, providing actionable insights for product improvement.
Conduct test data analysis, identifying outliers, generating data plots, and interpreting statistical outputs.
Lead team in DMAIC problem solving to identify and address root cause where gaps between performance and targets exist.
V&V Leadership
Provide technical leadership across multiple product lines & define best practices and technology roadmaps.
Review and provide feedback on product specifications, user needs and design inputs to ensure requirements are verifiable/validateable and contribute to product safety and efficacy.
Own the creation of new methods for design characterization to allow selection of optimal design concepts and process technology where assigned.
Design flows of testing to optimize cost, time, and accuracy of data generated, and own submission of lab requests based on these designs.
Develop robust, statistically sound test methods, including tensile, friction force, bending, leak, simulated use, fatigue, and dimensional measurement methods, that minimize sources of variability and product risks.
Lead execution, review, and optimization of test flow design, test method training, execution, and documentation, and statistical analysis (DOE, Gage R&R, TMVs) working with engineers and technicians.
Act as accountable owner for key V&V deliverables such as Test Method Development and Validation, DV plans and protocols, statistical analysis of data, V&V reports, Statistical Sampling Requirements, and Characterization Testing.
Leadership, Mentorship, and Training
Represent Teleflex in cross BU, regulatory, or standards forums.
Provide thought leadership & guidance to support junior and mid‑level V&V Engineers, training on statistical tools, test method validation execution, and V&V best practices.
Review and approve technical documentation, reports, and protocols and provide constructive feedback; capture and disseminate lessons learned and identify & implement continuous improvement opportunities.
Train and direct technicians in performing equipment qualifications, process characterization, test method validation execution, failure investigations.
Actively contribute to team growth by developing training materials and driving continuous improvement initiatives.
Education / Experience Requirements
Bachelor’s or technical degree in related field preferred.
10+ years of engineering product development experience required.
3+ years of experience in a leadership capacity.
7+ years of experience in design and development of medical devices.
7+ years of experience in document controlled systems using PLM and ERP software; Oracle Agile/SAP preferred.
Experience and proficiency in MS Office applications (Word, Excel, Outlook, Teams, etc.).
Proficiency in Minitab or similar statistical software.
Competencies
Instill 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.
Decision Quality
– Makes good and timely decisions that keep the organization moving forward. Makes sound decisions, even in the absence of complete information.
Plans and Aligns
– Plans and prioritizes work to meet commitments aligned with organizational goals; sets objectives to align with broader organizational goals; breaks down objectives into initiatives and actions; stages activities with milestones and schedules; anticipates and adjusts contingency plans.
Cultivates Innovation
– Creates new and better ways for the organization to be successful. Comes up with useful ideas that are new, better, or unique; introduces new ways of looking at problems; can take a creative idea and put it into practice; encourages diverse thinking to promote and nurture innovation.
Optimizes Work Processes
– Knows the most effective and efficient processes to get things done, focusing 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.
Specialized Skills / Other Requirements
Prefer 15+ years in device development with sustained record of technical leadership and enterprise impact.
Excellent oral and written communication skills. Proficient at communicating effectively across functions to achieve common goals.
Ability to manage dynamic workload and prioritize small and large tasks efficiently.
Working knowledge and experience implementing Good Documentation Practices (GDP).
Advanced knowledge of technologies related to catheter testing and relevant standards, such as ISO10555, ISO80369, etc.
Experience with and working knowledge of ISO13485 & FDA requirements.
Advanced knowledge and experience with IQ, OQ, and PQ validation, DV and TMV testing of medical devices including creating supporting documentation.
Working knowledge of mechanical drawings, product requirements and engineering specifications.
Attention to detail. Ability to manipulate small pieces of data with accuracy and focus, identifying information that does not fit and implementing solutions.
High mechanical aptitude and strong problem solving/decision‑making skills. Ability to think critically and implement solutions independently.
Thorough understanding of process statistics, inspection, equipment, risk management, metrology and calibration.
The pay range for this position at commencement of employment is expected to be between $144,560.00 to $216,840; 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. If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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 Talent@Teleflex.com.
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