Senior Project Engineer

About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.



Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This Sr. Project Engineer is responsible for sustaining engineering projects related to Teleflex’s Respiratory products. Under minimal direction, the incumbent will organize and manage multiple projects and ensure they are completed in a timely manner, developing creative solutions to existing products when problems arise or modifications are requested.

Principal Responsibilities
Conduct research on projects associated with the design and/or design modifications of medical devices, components, models, or mechanisms.
Prepare or coordinate formal documentation of the product Designs, Risk Analysis, Product Specifications, Market Specifications, etc. according to established Product Development Procedures, and initiates formal reviews to get approved per said procedures.
Develop, maintain, and publish product development plans for assigned projects with critical milestones and timelines.
Develop and coordinate the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.
Investigate and resolve technical problems involving product performance, production equipment, or facility systems affecting production.
Coordinate the product design and development process with appropriate support departments such as engineering, regulatory, documentation, tooling and manufacturing.
Serve as project leader for assigned projects and follow up on all aspects of projects, including conducting reviews with support groups and outside resources where applicable.
Prepare or follow up on preparation of design drawings, specifications, cost estimates, mainframe updates, etc.
Discuss and consult with sales staff or customer on product requirements and specification where design or manufacturing problems are involved.
Work with manufacturing in the justification and the selection of the manufacturing process. Assign projects and establish priorities to ensure timelines and goals are achieved.
Develop assembly methods and procedures. Create engineering drawings and specifications.
Coordinate changes in process, tooling, and equipment identified to positively impact the manufacturing process, while staying within design control guidelines.
Coordinate the reporting on project status for all responsible projects to include cost reduction, progress, and capital spending and expense status. Present reports in formal periodic project review meetings.
Enhance personal growth and development through participation in education programs, current literature, training meetings and workshops.
Participate actively in continuous quality improvement activities through compliance with safety standards.
Demonstrate professional responsibilities by cooperating with other personnel to achieve department and interdepartmental goals and objectives and maintain good employee relations.
Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
Analyze complex, technical and administrative problems and adopt an effective course of action.
Conduct comprehensive studies and preparation of reports including recommendations.
Make effective presentations to, and participate in, a variety of meetings and conferences with other companies and the public.
Prepare clear and concise statements and reports.



Education / Experience Requirements
Bachelor’s Degree in Engineering or closely related field.
Minimum 5-7 years of work experience with medical device design. Focus on disposable devices preferred.
Injection molding, plastic extrusion and plastic part assembly process and methods
Experience with CAD (design/drafting) programs, eg: SolidWorks, preferred.



Specialized Skills / Other Requirements
Solid understanding of and experience with:
o U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices.

o ISO and ASTM testing methods for medical devices and general plastic components

o Principles and practices of professional engineering.

o Regulations pertaining to medical device design and design modifications.

SAP and Agile experience preferred.
Demonstrated creativity and ingenuity in applying engineering principles and practices and drawing solutions from a wide range of experience.
Effective written and oral communication skills and ability to present information to, and respond to questions from, various audiences.
Ability to interpret and follow instructions furnished in written, oral, diagram, or schedule form.
Intermediate knowledge of Microsoft Office Suite (Project, Word, Excel, and Access)
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Proven ability to establish and maintain effective working relationships with peers.
Fluency in English (spoken and written)



Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.
Teleflex is an equal opportunities employer

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