Expected Travel: Up to 25%
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.
Anesthesia and Emergency Medicine-At Teleflex, we promote the use of advanced anesthesia and emergency medicine techniques to help improve outcomes and reduce healthcare costs. We equip clinicians with some of the most advanced medical devices on the market today, from our world-class brands including:
• LMA® and Rüsch® airway management devices designed to help reduce the risk of airway-related complications
• Arrow® pain management products designed to improve patients' post-operative pain experience
• The Arrow® EZ-IO® System that helps address the time-critical challenge of emergency vascular access, and
• QuikClot® and QuikClot Control+® hemostatic devices, used by hospitals, EMS, and the military for hemorrhage control in a broad range of bleeding situations.
Join a dynamic, growing team that offers healthcare providers advanced medical technology solutions that make a difference in patients' lives.
The Manager, R&D Sustaining position is responsible for the Sustaining Engineering functions for the Anesthesia and Emergency Medicine Business Unit. With minimal direction, this Morrisville, NC based position is responsible for management of sustaining changes within the current Design Controls maintained by Teleflex policies and procedures. Changes include factory supporting projects which require R&D oversight and review, R&D-led remediation projects, supplier-initiated changes, product enhancements, product line extensions, and cost/continuous improvement projects. The manager organizes and manages multiple projects led by the team, and ensures projects are completed in a timely manner. The manager prioritizes and assigns work appropriately to meet business unit objectives. The manager facilitates creative solutions to existing products when problems arise or when modifications are required. The position includes direct management of R&D engineers with areas of expertise in project engineering, mechanical, electrical, process and/or tooling. The manager ensures cross-functional project teams supporting sustaining efforts complete projects within design control procedures in a timely manner. The position may also be responsible for individual project management.
Incumbent for this role performs at the manager level within the Research and Development field including complex studies and projects requiring analysis, where extensive research may be required to develop suitable solutions. Must develop strong inter-departmental relationships. Incumbent at this level will receive only occasional instruction or assistance and are fully aware of the operating procedures and policies of the department. The manager must have the ability to be an individual contributor if necessary by acting as lead to select projects while managing engineers, project teams and product evaluation lab efforts effectively.
- Conducts or leads team in research or development projects associated with the design and design modifications of medical devices, components, systems, or mechanisms.
-Ensures staff prepares or coordinates formal documentation of the product design, risk analysis, product specifications, etc. according to established Design Control procedures, and initiates formal reviews for approval.
-Responsible for remediation and update of Design History Files, Technical Files or other product registration efforts as required.
- Responsible to ensure Design History Files and Technical Files are current to required regulatory requirements.
-Ensures staff is trained to all current procedures and regulatory requirements for successful performance of their positions.
-Develops, maintains and publishes product development plans for assigned projects with critical milestones and timelines.
-Coordinates the product design and development process with appropriate support departments such as new product development, quality engineering, regulatory, product data/documentation, operations.
- Assigns project leaders for projects and is responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable.
-Ensures staff prepares or follows up on preparation of design drawings, specifications, estimates of costs, system updates, etc.
-Discusses and consults with marketing, sales, CMA and/or clinical user/customer on product requirements and specification where design or manufacturing issues or changes are involved.
- Works with manufacturing and other supply chain stakeholders in the justification and the selection of the manufacturing processes, vendor selection, etc. Assigns projects and establishes priorities to ensure datelines and goals are achieved.
- Coordinates the reporting on project status for all responsible projects and directs reports in formal periodic project review meetings, which include cost reduction, progress, capital spending and expense status.
-Enhances growth and development through participation in education programs, current literature, training meetings and workshops. Ensures growth and development opportunties are achieved for the team members.
- Mentor for subordinate engineers and staff.
-Participates actively in continuous quality improvement activities through compliance with safety standards.
- Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental and business unit level goals.
-Maintains compliance with principles of accepted employee conduct as identified in the Teleflex employee handbook and as specified in departmental policies and procedures.
- Performs other related duties as assigned or requested.
Education / Experience Requirements
• MS or BS degree in engineering or closely related field
• Minimum of eight (8) years of progressively responsible engineering experience
• Minimum of two (2) years of an engineering lead/manager capacity
• Recent medical device and plastic part design experience is mandatory
• Previous experience in new product development or sustaining engineering preferred
• Manufacturing operations or process engineering experience preferred
Specialized Skills / Other Requirements
• Demonstrated passion and enthusiasm for leadership and team development
• CADD drafting/design program - SolidWorks preferred
• Injection molding, plastic extrusion, plastic part assembly and methods
• Basic lab principlesand operation
• FDA, GMP, ISO regulated industry experience
• Design, validation, manufacturing processes experience
• Design assurance/risk management experiece
• ISO and ASTM testing methods for medical devices and plastic components
• Technical staff management experience
• Demonstrated problem solving, creativity and ingenuity in applying engineering principles and practices
• Effective presentation of information to peers, senior managers and leadership, customers, vendors, etc.
• Effective interface with operations management and personnel
• Develop and manage project/department budgets; obtain outside quotations for products & services
• Conduct personnel evaluations for direct reports; oversee employee development
• Speak and write English fluently
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.
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