Sr. Principal Engineer, Verification & Validation, R&D

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.

Principal Responsibilities

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.
•    Where gaps between performance and targets exist, lead team in execution of DMAIC problem solving to identify and address root cause.
V&V Leadership:
•    Provides technical leadership across multiple product lines & defines 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.
•    Where assigned, own the creation of new methods for design characterization to allow selection of optimal design concepts and process technology.
•    Design the structure of flows of testing to optimize cost, time, and accuracy of the data generated, and own the 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.
•    Working with engineers and technicians, lead execution, review, and optimization of test flow design, test method training, execution, and documentation, and statistical analysis (DOE, Gage R&R, TMVs).
•    Serve as the 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:
•    Represents Teleflex in cross BU, regulatory, or standards forums.
•    Provides thought leadership & guidance to support junior and mid-level V&V Engineers, providing training on statistical tools, test method validation, 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 Proficient in MS Office applications e.g., Microsoft Word, Excel, Outlook, Teams, etc.
•    Proficiency in Minitab or similar statistical software. 

COMPETENCIES: - incumbent must have proven abiilty to:

•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 appropriate initiatives and actions; stages activities with relevant milestones and schedules; anticipates and adjusts effective 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, 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.

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 implement solutions.
•    High mechanical aptitude and strong problem solving/decision-making skills. Ability to think criticaly 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.

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