Principle Engineer, Global Packaging

Date: Nov 16, 2021

Location: Morrisville/ US Remote, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 5095 

 

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 Functions The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This is a high visibility high impact Principal level packaging SME role, which will lead strategy, innovation, execution, and delivery for Global Operations. This position can be remote for the right candidate. 

Act as the main process and equipment expert driving best practices in accordance with ISO11607. Drive key projects for operations that will include process, design, testing, verification, and validation of sterile and non-sterile packaging for medical products for the Global Teleflex Packaging team. Package design activities include risk analysis, design input, design output, design verification and validation, and design transfer per the Teleflex Design Control policies and procedures, and adherence to all applicable global package integrity and protection standards. Main oversight for process development, validation practices and implementation activities within Teleflex manufacturing sites, contract manufacturers or strategic suppliers as required. Lead updates to the product device master records (DMR), design history files (DHF) or internal SOPs/Work Instructions in compliance with the Teleflex Quality System. 
 

Principal Responsibilities

•    Act as a Principal level Process & Equipment innovation SME for Global Packaging and drive decision-making in coherence with ISO11607. 
•    Drive and execute key projects.
o    Drive standardization of packaging manufacturing practices e.g. process validations & revalidations, test methods, process monitoring etc. 
o    Oversee redesign of existing packaging systems and manufacturing processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner.  
o    Work with mfg. site and BU cross-functional teams to develop medical device packaging, specifications and processes with input from the packaging industry, physicians, marketing and manufacturing adhering to the design control process. Partner with Logistics & Distribution teams to ensure that the packaging design meets the requirements of palletization, sterilization, distribution and delivery. 
o    For both in-house and purchased packaging systems/components, coordinate the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Generate product, process and experimental activity specifications for the Device Master Record as required.
o    Lead and oversee development/improvement of packaging design & processes by utilizing tools such as DOE and statical analysis; assist in implementation with appropriate controls and metrics.
•    Facilitate training, procedure, process and geography requirements per ISO11607.
•    Create and maintain dashboard for mfg. site projects. Escalation of critical issues/concerns/priorities to PKG and Ops leaders. Support Packaging issue resolution for Quality/Service/cost for Global Packaging priorities.
•    Support resource assessment & projects prioritization.
•    Support strategic goals and objectives for Operations.
•    Support AOP planning and budget adherence.
•    Site level support and integration to Audit process and to any Audit findings.
•    Drive key learnings across function to ensure lessons learned culture.
•    Conduct or coordinate package testing in the internal Teleflex Packaging Lab or with external testing services providers.
•    Aid the site project teams in meeting project objectives, milestones, and target dates. Update and review project progress on an as-required basis.
•    As requested, work with the Product Performance Team and R&D personnel to lead investigation of product complaints involving packaging to determine root cause and implement corrective action.
•    Support packaging assessments, review of industry standards updates, product regulatory submissions and/or limited market evaluations/clinical trials as required.
•    Ensure projects are developed and documented compliant with the Teleflex Quality System.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    Bachelor of Science or Professional Engineer (PE) Certification – Engineering or technical discipline (Packaging Science or equivalent degree). Masters degree preferred. 
•    Min.12 years (min. 10 years with Masters) of relevant experience (product design, machine design, manufacturing processes, medical device and/or pharmaceutical – e.g. Must have Co-op/Internship, general work). Core medical device experience highly preferred.
•    Deep experience with ISO11607 application is required.
•    Deep experience in medical device sterile barrier packaging designs, packaging sealing technologies, process, and testing is highly preferred. 
•    Good familiarity with sterilization methods & material compatibility is highly preferred.
•    Experience driving standardization of packaging operations techniques is highly preferred.
•    Good familiarity with statistical techniques.
•    Strong analytical and problem-solving skills.
•    Effective verbal and written communication skills.
•    Team player with good interpersonal skills.
•    Proficient in Microsoft Office Suite and computerized analysis applications.
 

Specialized Skills / Other Requirements

•    Self-motivated, high energy, collaborative, positive attitude individual with the initiative and drive for timely completion of goals.
•    Able to travel domestically and internationally.
 

 

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: Raleigh