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Design Quality Engineer II

Date: Apr 19, 2024

Location: Mansfield, MA, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :10064

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.

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Design Quality Engineer will be responsible for ensuring the quality and reliability of products throughout the design and development process. The primary responsibilities of the Design Quality Engineer will include assessment of all process and design changes applicable to Performance Fiber private labelled and contract manufactured devices.

• Strong negotiation and problem solving skills

• Excellent listening, verbal and written communication skills

• Statistical skills preferred (e.g., DOE, SPC, Gage R&R).

• Excellent decision making, time management and reasoning ability

• Excellent interpersonal skills with a demonstrated ability to work in a team

• Ability to multi-task, prioritize, and adapt to shifting priorities

• Ability to work with minimal supervision

Principal Responsibilities

• Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.

• Create and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.

• Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into its risk file to reflect its current risk profile. Support Clinical and Medical Writers in the analysis of available clinical data, as required.

• Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design, and analyze experiments, determine process and performance capability, and make statistically supported decisions.

• Apply the most relevant and useful quality philosophies throughout Design Control and its related processes for both new product development and sustaining. Understand and manage work to minimize cost of quality throughout the product’s lifecycle.

• Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.

• Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.

• Partner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and technical complaints.

• Understand applicable external regulations and internal standards that drive compliance and apply them in their daily function. Perform audits of Design History Files and support both internal and external audits.

• Partner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development.

• Develop and validate test methods. Identify and apply metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conduct measurement system error studies such as Gage R&R.

• Perform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.

• Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.

• Define, identify, and apply product and process control methods such as developing control plans, identifying essential design outputs and critical control points, and developing and validating work instructions.

• Apply the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interpret and select variable, attribute, and zero-defect sampling plans.

• Apply supplier management principles and provide input on projects for supplier selection, quality expectation letters, supplier quality agreements, and process qualifications.

• Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.

• Generally, apply the above concepts as required at the local and departmental level.

Education / Experience Requirements

• Bachelor’s Degree in Engineering, Chemistry, Physical Science, or related field is preferred or 3+ years of Design Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will be considered)

Specialized Skills / Other Requirements

cGMP, QSR, ISO 13485 knowledge base required.

• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint. Ability in data-base development, statistical software and analysis, simulation, word processing for report generation, etc.

• ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred

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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: 877-880-8588 or Talent@Teleflex.com.

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.