Process Development Engineer 2 jobs in United States
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Teleflex · 20 hours ago

Process Development Engineer 2

Teleflex is a global provider of medical technologies dedicated to improving health and quality of life. The Process Development Engineer 2 will provide technical support for medical device operations, focusing on process development, validation, and troubleshooting while collaborating with cross-functional teams.

CommercialHealth CareMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Establish processes based on product specifications
Develop processes, fixtures, and equipment for site requirements
Support Production and R&D with frequent communication
Ensure that proper technology processes are developed, implemented, maintained and documented to successfully transfer development products to Production. Involved in prototyping, process development, confirmation runs, and validation
Perform equipment and process qualifications (IQ/OQ/PQ)
Develop Control Plans, Gage R&R’s, Test Method Validations, and pFMEA
Transfer product/processes from R&D to Manufacturing using project management, Design for Manufacturability and cost, process/design excellence, ergonomics, and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology
Provide onsite support for troubleshooting manufacturing problems on assigned development projects
Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality, and process costs
Maintain knowledge of new developments in manufacturing and design technologies
May lead or serve as member on cross-functional project teams
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Perform other related duties and responsibilities, as assigned

Qualification

Medical Device ExperienceManufacturing ProcessesProject ManagementFDA DocumentationSolidWorksPrioritizeCommunication SkillsProblem Solving

Required

Bachelor's degree in engineering with a focus in Plastics, Biomedical, Mechanical or related technical field is required
A minimum of 2 years of engineering experience is required
Experience in medical device industry or in a regulated manufacturing environment (ISO, FDA, etc.) is required
Working knowledge of manufacturing processes related to catheter production including braiding, coiling, extrusion, injection molding, reflow and packaging
Proven track record for project management, problem solving, sound decision making and project completion; the ability to manage development programs across multiple locations and project teams
Familiar with FDA documentation requirements, QSR requirements for medical devices, Lean Manufacturing and Good Manufacturing Practices
Experience with Microsoft Word/Excel is required
Excellent oral and written communication skills are required. Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations
Ability to prioritize and work independently
Behaviors consistent to support a quality and safety driven culture

Preferred

Experience in catheter manufacturing or development is preferred
Experience with Solidworks, Microsoft Project and MiniTab is preferred
Working knowledge of GD&T with proficiency in SolidWorks or equivalent CAD software

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