Principal Engineer, Process Dev, R&D jobs in United States
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Teleflex · 3 hours ago

Principal Engineer, Process Dev, R&D

Teleflex is a global provider of medical technologies committed to improving health and quality of life. The Principal Engineer in Process Development will lead a team to define and execute process development strategies for new medical products, ensuring they meet clinical needs and manufacturing requirements.

CommercialHealth CareMedicalMedical Device
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H1B Sponsor Likelynote
Hiring Manager
Lexy (Mayer) Cianfrani
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Responsibilities

Lead a small team of engineers to define and effectively execute the process development strategy
Represent the process development function on the core team through collaboration, strategy, technical knowledge, and communication
Manage the planning, execution, and documentation of all process development & validation activities for new products based on, projected product volume, project timelines, and COGS targets
Actively pursue design, process, and equipment improvements to improve process reliability and minimize product manufacturing cost
Make process decisions that minimize process issues and resolve those that occur
Specify, design, characterize, optimize, and implement manufacturing processes that are capable of meeting design, quality, productivity, and cost requirements
Investigate and troubleshoot process issues, determine causes, and implement solutions
Develop and implement easy to follow work instructions to produce products that meet requirements
Establish project timelines, track progress, manage to the schedule, and communicate project status to management and project leader
Lead generation of product development process documentation (e.g., PFMEAs, characterization studies, protocols, reports, MPs, Design Transfer reports, etc.)
Plan, coordinate, and execute process validations. Transfer validated processes and equipment into production for commercial manufacturing
Coordinate with production to produce initial finished goods inventory for new product launches
Perform test data analysis
Conduct risk analysis, failure analysis, and root cause investigations and report the results
Coordinate and execute product development builds
Build partnerships and collaborate with others to meet shared objectives
Work effectively in a diverse group, respect different ideas, perspectives, and values

Qualification

Process DevelopmentMedical Device ExperienceProcess ValidationData AnalysisCatheter ManufacturingProject ManagementProblem SolvingCollaborationCommunicationAttention to Detail

Required

BA/BS in Engineering or physical sciences required
8 years of related experience required
Expert-level experience working in medical device catheter process development
Expertise in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle

Preferred

MS in Engineering or physical sciences preferred
Experience successfully leading a process development team through a catheter development project from concept to commercialization
Expert level experience with many of the processes and process aids used in catheter manufacture; polymer laser bonding, hot die polymer bonding, UV adhesive bonding, injection over-molding, catheter reflow, marker band swaging, metal laser bonding, roll-cut, pressure testing, tipping, heat shrink, mandrels, balloon pleat and fold, laser micrometer, optical micrometer, balloon forming, nitinol forming, nitinol laser cutting, braid reinforcement, coil reinforcement, induction heating, hydrophilic coating, silicone coating, packaging, PTFE liner stretch, assembly, metrology, inspection, and fixtures
Knowledge of the first principles behind catheter processing
Knowledge of poka-yoke tools and implementation
Recognized as having a knack for independent problem solving of mechanical and/or electrical systems
Persistent in achieving success using a productive and positive approach
Experience using Minitab to perform data analysis (including DOE, ANOVA, hypothesis testing, gauge R&R, capability analysis, normality analysis, distribution identification, graphing, etc.)
Demonstrated project management skills and ability to coordinate multiple projects simultaneously

Benefits

Medical, prescription drug, dental and vision insurance
Flexible spending accounts
Participation in 401(k) savings plan
Various paid time off benefits, such as PTO, short- and long-term disability and parental leave

Company

Teleflex

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Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.

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 Company
Total Funding
$400M
2016-05-12Post Ipo Debt· $400M
1990-01-01IPO

Leadership Team

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Liam Kelly
Chairman, President and CEO
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Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
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Company data provided by crunchbase