Process Development Engineer, MDR
Teleflex

Chelmsford, Massachusetts

This job has expired.


Expected Travel: None

Requisition ID: 4612

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.

US COVID-19 Vaccination Requirements

Teleflex is focused on the health and safety of our employees, their families, and our customers. Teleflex will comply with US government regulations regarding COVID-19 vaccination requirements for US workers. To ensure we are prepared for all applicable vaccination requirements, Teleflex is currently collecting vaccination status and accommodation requests from our US based employees.

Employees and new hires in sales or field-based roles that require vendor credentials to access medical facilities as an essential function of the job, may be required to obtain the COVID-19 vaccination based on customers/site requirement. This requirement is independent of Teleflex policy or any applicable US governmental regulations.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

• To develop and document manufacturing processes capable of producing products meeting design specifications and cost targets in a timely and efficient manner.
• To plan, coordinate, and execute process validations and transfer validated processes and equipment into production for commercial manufacturing.
• Coordinating with production to produce initial finished goods inventory for new product launches.

Principal Responsibilities

• Plan process development & validation activities for new products based on; projected product volume, project timelines, and COGS targets.
• Establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader.
• Identify, specify and coordinate development, sourcing and qualification of: equipment, tooling, fixtures and component materials to produce product per design specifications.
• Accurately document characterization studies, develop validation build records, independently generate OQ and PQ protocol and report documents.
• Generate documentation as outlined in the Process development process (e.g. PFMECAs , protocols, reports, MPs, Design Transfer reports, etc.)
• Train PD technicians, production operators and manufacturing technicians
• Conduct test data analyses including: identification of outliers or non-normal data, generating data plots, general statistical analysis, and determining process capability.
• Conduct Risk Analysis, Failure Analysis and Root Cause investigations and report results
• Work with PD technicians to perform and document equipment qualifications and process characterization.
• Develop and conduct experimentation using scientific methods (ie. Design of Experiments) to determine suitable process boundary conditions to achieve output requirements.
• Investigate and troubleshoot process issues, determine causes, recommend and implement solutions.
• Conduct line flow analysis and measure production cycle time vs established goals, identify inefficiencies, propose and implement solutions

Note: 100% of this job involves direct R&D activities

Education / Experience Requirements

• BA/BS in Engineering or physical sciences required

Specialized Skills / Other Requirements

• Demonstrated project management skills and ability to coordinate multiple projects simultaneously
• Capability to perform process qualification and validation activities including risk assessment, range finding, DOE and process documentation
• General knowledge of Quality System methodologies and regulations associated with the medical device industry
• Basic understanding of process validation (IQ, OQ & PQ), familiarity with various production processing methods and the product/process development cycle
• Proficiency in MS Office applications, strong written and verbal communication skills, ability to read and understand technical drawings, product requirements and specification documents
• Must be capable of independent problem solving and have sufficient understanding of statistical techniques to perform data analyses and process capability analyses

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.


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