R&D Manager, Hemostasis
Teleflex

Job Info

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Expected Travel: Up to 10%

Requisition ID: 8044

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 QuickClot 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.

Position Summary

The R&D Manager, Hemostasis directs the Research and Development Hemostasis New Product Development (NPD) team activities for Anesthesia and Emergency Medicine (AEM) hemostasis products.

With formal responsibility for NPD projects from conception to launch, this position is also a working engineer and will be responsible for the development and maintenance of documentation and testing as assigned; organization and management of multiple projects, ensuring projects are completed in a timely manner; creation of design ideas for new products as well as creative solutions to existing products when the need arises or modifications are requested; and performance of other related duties as required.

This position also ensures resources are available for scheduled project activities and provides an interface between Hemostasis R & D efforts and senior Teleflex management. The Manager ensures the requirements of Quality Assurance and Regulatory Compliance programs are met for the projects under development, provides scientific and technical advice and support to Senior Management as well as project team, and works with Global Marketing to establish Market Driven development programs.

The Manager coordinates the new product development efforts to support the global requirements for AEM hemostasis products and has project prioritization responsibility for development of personnel.

DISTINGUISHING CHARACTERISTICS:
Incumbent in this class performs the advance level scope of assignments in the research and development field including complex studies and projects requiring analysis, extensive research, unusual or original solutions, and inter-departmental relationships. Incumbent at this level receive only occasional instruction or assistance as new or unusual situations arise and are fully aware of the operating procedures and policies of the work unit; will act as lead on projects and guide direct reports and outside departments.

Principal Responsibilities

1. Coordinates and drives development teams to complete projects and activities on time. Serves as the project leader and owns responsibilities for project management for assigned projects, including follow up on all aspects of projects and reviews with support groups and outside resources where applicable.
2. Responsible for project budgets.
3. Conducts research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms.
4. Prepares and coordinates formal documentation of Design Control and Stage Gate (C2C) requirements including product drawings, product specifications, market specifications, etc. according to established Product Development Procedures, and owns formal reviews (including design reviews) to get approved per procedure.
5. Develops, maintains, and publishes product Design and Development Plans that include critical milestones and timelines.
6. Develops and coordinates the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.
7. Investigates and resolves technical problems involving product performance, production equipment or facility systems affecting production.
8. Coordinates the product design and development process with appropriate support departments including marketing, regulatory, labeling, design assurance, and manufacturing.
9. Prepares or follows up on preparation of design drawings, specifications, estimates of costs, design control documentation, stage gate documentation, etc.
10. Discusses and consults with marketing and end users on product requirements and specifications.
11. Works with manufacturing in the justification and the selection of manufacturing process.
12. Assigns projects and establishes priorities to ensure deadlines and goals are achieved.
13. Creates engineering prototypes, drawings, and specifications.
14. Coordinates changes in process, tooling and equipment identified to positively impact the manufacturing process, while staying within GMP guidelines.
15. Coordinates the reporting on project status and directs reports in formal periodic project review meetings, which include overall project progress, capital spending and expense status.

MARGINAL FUNCTIONS
1. Enhances growth and development through participation in education programs, current literature, training meetings and workshops.
2. Participates actively in continuous quality improvement activities through compliance with safety standards.
3. Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
4. Maintains compliance with principles of accepted employee conduct as identified in the Teleflex Medical employee handbook and as specified in departmental policies and procedures.
5. Performs other related duties as assigned or requested.

Education / Experience Requirements

• Minimum of BS degree in engineering or closely related field, MS degree preferred.
• Experience with biomaterials and/or textiles preferred.
• Experience with combination products preferred.
• Minimum of ten (10) years of progressively responsible, professional engineering experience, two (2) years of which in an engineering lead capacity in the appropriate specialty creating and designing solutions to products.

Specialized Skills / Other Requirements

Required Skill Sets:
• Creating and editing drawings in SolidWorks.
• Microsoft Office Suite, (Project, Word, Excel and Access).
• Project planning software such as Microsoft Project or SmartSheet
• U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices.
• ISO and ASTM testing methods for medical devices.
• Principles and practices of professional engineering.
• Regulations pertaining to medical device design and design change.

Ability To:
• Develop teams and drive projects to completion.
• Create and maintain project schedules.
• Demonstrate creativity, ingenuity, and clear problem solving skills in applying engineering principles and practices.
• Draw solutions form a wider range of experience.
• Effectively present information and respond to questions from management and other cross functions.
• Organize, evaluate, and coordinate engineering studies with technical staff.
• Analyze complex, technical and administrative problems and adopt an effective course of action.
• Conduct comprehensive studies and prepare reports including technical justifications and recommendations.
• Make effective presentations to and participate in a variety of meetings with vendors/suppliers.
• Establish and maintain cooperative relationships with those contacted in the course of work.
• Prepare clear and concise presentations and reports.
• Establish and maintain cooperative relations with those contracted in the workplace.
• Develop direct reports, establishing goals and personal development plans.
• Speak and write English fluently.

WAGE RANGE/RATE: $125,000 - $140,000 based on experience and qualifications

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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.

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