- 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.
- Minimum of a Bachelor's degree in Engineering, preferably Mechanical Engineering
- Minimum of 5 years' experience supporting manufacturing, preferably medical devices.
- Experience with FDA QSR process and validation documentation requirements a plus.
- Experience with IQ/OQ/PQ and P/DFMEA
- Project management experience demonstrating 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
- Has a Sense of Purpose & Inspires others
- Has a desire & ability to "step up"
- Takes accountability
- Demonstrates critical judgement
- Communicates with Impact
- Builds and sustains relationships
- Plans and Organizes
- Is present & available
- Develops Leaders
- Builds High Performance people & teams
- Invest in personal growth
- Develops Organization capability
- 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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Manufacturing Engineer III - Chelmsford, United States - Teleflex
Description
Expected Travel:None
Requisition ID: 9689
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 visitGlobal 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
The 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.
The Manufacturing Engineer III primary function is to provide day to day support of the catheter manufacturing floor operations 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.Principal Responsibilities
Education / Experience Requirements
Specialized Skills / Other Requirements
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:or
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose.
Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.
