SPC Engineer

Date: Jun 2, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 4054


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.


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

Statistical Process Control Subject Matter Expert for the Plant(s) assigned.

Principal Responsibilities

•    Participate in the Creation of and Implementation of the Global SPC Playbook – the standard methods and practices for SPC Implementation across Global Operations
•    Infinity Application Software (SPCEE and Database Manager)
•    Create/Modify projects (in adherence to existing standards)
•    Create/Modify database structure (Part names, Machine names, Parameter names, etc.)
•    Create/Maintain specification limits
•    Infinity Automation Software (DMS and DCS)
•    Create/Modify configurations in DMS to retrieve/process data from OPC server tags, flat files  and external databases 
•    SPC-related activity
•    Evaluate data for historical stability and generate/apply statistical control limits where applicable
•    Assist with creation/application of corrective action information
•    Assist with generation of system metrics
•    Facilitate impromptu and scheduled meetings to address identified process/product issues 
•    Interface with production personnel
•    Training for general SPC and usage of specific projects
•    Troubleshooting issues on the shop floor
•    Interface with technical personnel
•    Training for usage of the dashboard and reporting functionality
•    Exploratory Data Analysis of historical data
•    Interface with management personnel
•    Generate/Review system metrics and reporting mechanisms

Other Proactive Quality Job Responsibilities:
•    Process improvement & Data Analysis
•    Design/Analyze designed experiments (DOE)
•    Design/Analyze Gage R&R studies
•    Process Characterization
•    Track/Trend process capability and product performance
•    General resource for statistics consultation
•    Process Control 
•    Generate/maintain process control plans
•    Participate in PFMEA activity
•    Strong understanding of Process Models and Sources/Nature of Process Variability

Database Validation 
•    Active member of SPC software validation team
•    Process & Test Method validation – statistical resource

Education / Experience Requirements

•    BS Degree in technical discipline (engineering, mathematics, statistics, …) 
•    QE, Black Belt, Lean certifications desired.

•    Expertise in SPC, DOE, Gage R&R required.
•    Demonstrated ability with Microsoft Office (Excel, Word)
•    Experience with general purpose statistical software (preferably Minitab)
•    Prior experience with InfinityQS SPC software a plus.
•    Ability to Mentor other Engineers and Technical personnel on Process Control Concepts
•    Experience in regulated industry (preferably medical device)


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: Boston