Manufacturing Engineer III (Chelmsford, MA, US) presso None

Position Summary

Manufacturing Engineer III will have capability within engineering disciplines to support Manufacturing and Quality Compliance efforts throughout the business. Provide support as an engineering resource on cross functional teams focused on sustaining and implementing continuous improvements to Teleflex catheter product lines.  These product lines include Intra-Aortic Balloon (IAB) catheters, pacing catheters, thermodilution catheters, cholangiography catheters, sheath introducers, Berman angiographic balloon catheters, and Wedge pressure catheters and new IAB Willow catheter.

The Manufacturing Engineer III primary function is to provide day to day support for the new Willow catheter new product development injection molding processes and assembly processes from an engineering perspective.  The engineer will drive investigations tied to non-conforming product as well as processing general Non-Conformance (NC) tasks.  In addition, the Manufacturing Engineer III is responsible for driving continuous improvement projects focused on the manufacturing line to reduce costs, while maintaining quality compliance, using the application of lean problem- solving tools.  Accountable for deliverables in good documentation practice, the design control process, and other required methods of documentation.  Experience with IQ/OQ/PQ and P/DFMEA is required, experience with Lean Principles is preferred.

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.

Principal Responsibilities

•    Ensure production-specific metrics, such as yield, efficiency, etc. are met and sustained.
•    Lead investigations tied to Non-Conformances, Complaints, and CAPA. Produce as team member or leader of investigative team as required for leadership or engineering technical assistance.
•    Lead engineering actions identified though production visual management boards
•    Source, plan, present, and deliver significant projects targeted at reducing waste, increasing productivity, and reducing stress on the operations and its operators.   Demonstrate competency in the use of the tools of improvement – Six Sigma and Lean Tools associated with the Teleflex Production System (TPS).  
•    Create and update manufacturing and engineering documentation (Work Instructions, SOPs, Specifications, Engineering Drawings, etc.) and perform training as necessary.
•    Demonstrated competence in process qualification and validation activity.  This activity includes authoring and executing validation plans, engineering studies, Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), and Test Method Validation (TMV) in accordance with ISO, FDA, and corporate guidelines. 
•    Support R&D activities as required utilizing technical skills to provide positive input to projects and to manage the transfer process from design to manufacturing. Ensure new platforms are capable of manufacturing in a cost-efficient manner. 
•    Demonstrate project management skills including but not limited to defining scope, identifying measurable results, methods, and resources necessary for improvement, timeline management and capable results.
•    Coordinate with production management in planning of and implementing the necessary technical changes required to sustain adequate production line capacity.
•    Provide technical leadership, mentoring, and supervision of Manufacturing Technicians.
•    Perform additional duties as requested to support the organization's needs.

Education / Experience Requirements

•    5 years of experience with a bachelor’s degree OR 3 years of experience with a master’s degree
•    Minimum of 3-5 years’ experience supporting manufacturing, preferably medical devices.
•    Experience with FDA QSR process and validation documentation requirements a plus.

Specialized Skills / Other Requirements

•    Experience with IQ/OQ/PQ and P/DFMEA
•    Experience with Injection molding equipment and processes (especially in Medical Devices)
•    Experience with Resins and other Polymers used in Injection Molding
•    Experience with Tooling used in the injection Molding processes
•    Project management experience demonstrates the ability to meet schedule and budget targets.
•    Experience in the development of production test fixtures is desirable
•    Proficient in most common PC based applications (Word, Excel, etc.)
•    Knowledge of Agile and SAP a plus
•    Knowledge of six-sigma and Lean manufacturing a plus.
•    Excellent communication, organization, and interpersonal skills
•    Ability to complete tasks and projects with minimal direction
•    Ability to provide work direction/mentor Technicians and other Engineers
•    Ability to effectively communicate with a wide variety of internal and external customers and/or suppliers 

Lead
•    Has a Sense of Purpose & Inspires others
•    Has a desire & ability to “step up”
•    Takes accountability
•    Demonstrates critical judgement 

Engage
•    Communicates with Impact
•    Builds and sustains relationships 
•    Plans and Organizes 
•    Is present & available 

Develop
•    Develops Leaders
•    Builds High Performance people & teams
•    Invest in personal growth 
•    Develops Organization capability

Improve 
•    Creates value for the customer 
•    Demonstrates Continuous Improvement via results. 
•    Creates a culture of inclusion & involvement
•    Makes the tough calls when organizations are not performing 

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Working Conditions / Physical Demands

TRAVEL REQUIRED:  No

WORKING ENVIRONMENT:
☒ Office/Professional        ☒ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory

The pay range for this position at commencement of employment is expected to be between $104,500 - $156,800 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.