Manufacturing Engineer, Wallingford CT

Date: Jun 10, 2021

Location: Wallingford, CT, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3926

 

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

Interfacing with Manufacturing and R&D, this Wallingford, CT based Manufacturing Engineer position will provide technical support and operating knowledge for Teleflex’s manufacturing operation, inclusive of the Z-Medica portfolio of hemostatic medical device. This position acts as a valuable resource in engineering functions, such as validating and troubleshooting processes, along with identifying and implementing continuous process improvements. The Manufacturing Engineer applies technical skills and a hands-on approach to medical manufacturing, working with cross-functional teams to solve problems and meet operational goals in a manner which complies with FDA, ISO standards and any other applicable external regulations.

 

Principal Responsibilities

•    Process development, DOEs, validation protocols for existing medical devices Develop, revise, and execute validation procedures and protocols (IQ, OQ, and PQ) as related to equipment and processes to ensure that products are manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices.
•    Identify, document, and investigate protocol deviations in conjunction with cross functional teams, as required to resolve and close out deviations.
•    Support Design Transfer phase of new product development projects by guiding manufacturability and process scale-up.
•    Develop, validate, and draft SOPs for manufacturing processes.
•    Maintenance of documentation and project progress in project plans throughout all phases of projects.
•    Coordinate activities with outside suppliers and consultants including validation protocol development and execution, and pFMEAs to ensure timely completion of projects.
•    Develop and administer budgets, schedules, and performance standards for projects lead.
•    Collaborate cross functionally to investigate new robust and innovative technologies in alignment with R&D and operations strategies.
•    Support MRB Activities including NC and SCAR.
•    Support sustaining engineering activities for products manufactured in house and at vendors.
•    Investigate or support investigations related to CAPA, IACA or Customer Complaints.
•    Participate in risk management activities.
•    Help develop and oversee the Preventive Maintenance activities.
•    Support continuous improvement initiatives.
•    Approval of validation reports.
•    Travel as needed (0% - 20%)
•    Perform other duties as assigned to support Quality System.

Education / Experience Requirements

Qualifications/Experience Requirements
•    Bachelor of Science in biomedical or mechanical engineering or related technical field, advanced degree in engineering is preferred
•    3 - 5 years of industry experience in medical device manufacturing
•    Advanced knowledge of statistical analysis techniques and tools
•    Ability to develop and write Work Instructions, Standard Operating Procedures, Design of Experiments, validation protocols, and sampling plans that are compliant to medical device industry standards.

Specialized Skills / Other Requirements

•    Microsoft Office experience (Word, Excel, and PowerPoint)
•    Knowledge in developing and implementing procedures, methods, and tools for the manufacture and testing of medical products
•    Expertise in conducting Failure Mode Effects & Analysis (FMEA) assessments and risk mitigation for processes
•    Skilled in generating test plans, writing protocols, conducting design verification/validation, and processing validation testing of new and modified designs or processes
•    Experience with manufacture of hemostatic agents/devices or biomaterials a plus
•    Experience in working with cross-functional teams and vendors/suppliers to complete projects
•    Ability to maintain confidentiality and discretion in business relationships
•    Familiarity with FDA, GMP, and ISO requirements for the validation, manufacturing processes, and assembly of medical components and devices
•    Knowledge of FDA QSR medical device regulation and ISO 13485 standard.
•    Must be able to give and receive constructive feedback; contribute to building a positive team environment
•    Strong communication and excellent technical writing skills.
•    Ability to work in a smaller hands-on environment.
•    Knowledge of medical & surgical terminology.
•    Experience with Design for Manufacturability/DRM/DFSS or similar methodology Green belt, Black Belt or Lean Manufacturing certified preferred.

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.


Nearest Major Market: New Haven
Nearest Secondary Market: Hartford