Teleflex · 2 days ago
Sr. Principal Engineer, Verification & Validation, R&D
Maple Grove, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$145K/yr - $217K/yr
10+ years expTeleflex is a global provider of medical technologies dedicated to improving health and quality of life. The Sr. Principal Verification and Validation Engineer will serve as a technical authority, leading V&V strategy and ensuring product excellence and compliance across multiple product lines.
CommercialHealth CareMedicalMedical Device
Hiring Manager
Debbie Riemer
Responsibilities
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
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
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
Qualification
Required
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
Proficiency in Minitab or similar statistical software
Excellent oral and written communication skills
Ability to manage dynamic workload and prioritize small and large tasks efficiently
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 critically and implement solutions independently
Thorough understanding of process statistics, inspection, equipment, risk management, metrology and calibration
Preferred
Bachelor's or technical degree in related field preferred
15+ years in device development with sustained record of technical leadership and enterprise impact
Experience and Proficient in MS Office applications e.g., Microsoft Word, Excel, Outlook, Teams, etc
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
Benefits
Medical
Prescription drug
Dental and vision insurance
Flexible spending accounts
Participation in 401(k) savings plan
Various paid time off benefits
PTO
Short- and long-term disability
Parental leave
Company
Teleflex
Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.
10001+ employees
H1B Sponsorship
Teleflex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (3)
2022 (2)
2021 (4)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$400M2016-05-12Post Ipo Debt· $400M
1990-01-01IPO
Leadership Team
Liam Kelly
Chairman, President and CEO
Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
Recent News
2025-12-18
2025-12-10
Company data provided by crunchbase