Process Validation Engineer

Position Summary

Under general direction, the Process Validation Engineer in our Morrisville, NC facility is responsible for the creation and revision of documentation of design history file records, engineering test records, and business process records required during the development and launch of a new manufacturing line and its associated products.  Assignments may include smaller task work for other products within the Teleflex portfolio. Experience and background requirements should focus on disposable medical device products. 
 
The candidate must be capable of completing assignments with an advanced level scope through all phases of the development and launch of this new manufacturing line. Incumbent at this level receives only occasional instruction or assistance as new or unusual situations arise and is fully aware of the operating procedures and policies of the work unit.
 
Term of employment is expected to coincide with the length of the new manufacturing process development project from initial development through final production-release change order for this process and its associated equipment. At this time, production release is projected to occur at the end of the 4th quarter of 2024.
 

Principal Responsibilities

•    Serves as R&D design controls lead on an integrated core team. Collaborates with Engineering, Quality, and Regulatory to understand technical targets and design control systems. 
•    Responsible to ensure Design History File documents and technical files are written and maintained to current Regulatory requirements for the project. 
•    Prepares formal documentation of the product designs, risk analysis, product specifications, market specifications, etc. according to established product development procedures.  Initiates formal reviews per said procedures.
•    Develops, maintains, and publishes equipment validation plans for assigned projects with critical inputs and outputs
•    Develops and coordinates protocols for the validation of new or modified devices or components including validations of design, manufacturing process, assembly, packaging, and sterilization where applicable.
•    Primary R&D interface with operations for project documentation
•    International efforts (travel, interface) are key, as role supports qualification of new manufacturing equipment through installation in Teleflex’s Chihuahua, MX manufacturing facility
•    Prepares or follows up on preparation of design drawings, specifications, estimates of costs, etc.
•    Consults with sales staff or customer on product requirements where design or manufacturing problems are involved.

•    Works with manufacturing on process activities and prioritizes document creation and flow to ensure project goals are achieved.
•    Creates engineering drawings and specifications.
•    Documents development of and changes to process, tooling and equipment identified to positively impact the manufacturing process, while staying within design control guidelines.
•    Demonstrates professional responsibilities by cooperating with other personnel to achieve project objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
•    Maintains compliance with principles of accepted employee conduct as identified in the Teleflex employee handbook and as specified in departmental policies and procedures
 

Education / Experience Requirements

•    Possession of bachelor’s degree in Engineering. Minimum 2-3 years of work experience in the development and processing of high-volume manufacturing processes.  Prior work in testing, validation and sustaining engineering is a plus, with close partnerships with manufacturing teams
•    Microsoft Office Suite, (Project, Word, Excel) 
•    Knowledge of injection molding, plastic extrusion and plastic part assembly processes and methods
•    U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices
•    SAP and Agile experience preferable
•    ISO and ASTM testing methods for medical devices and general plastic components
•    Principles and practices of professional engineering
•    Regulations pertaining to medical device and process equipment design and modification
 

Specialized Skills / Other Requirements

Skill Sets:
•    Strong written and verbal communication skills and attention to detail
•    Effectively present information and respond to questions from groups of managers, clients, customers, and the general public
•    Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
•    Make effective presentations to, and participate in a variety of meetings and conferences across multiple disciplines and Teleflex locations
•    Bilingual (Spanish/English) is beneficial

Ability To:
•    Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a process development department
•    Conduct comprehensive studies and preparation of reports including recommendations
•    Prepare clear and concise statements and reports.
•    Establish and maintain cooperative relations with those contracted in the workplace.
•    Speak and write English fluently.
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