Job Description

Expected Travel: None

Requisition ID: 7802

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 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

Sr. Manager, Asia Region AEM R&D is responsible for Kamunting and Kulim R&D and Sustaining Engineering functions for the AEM BU. This position is responsible to direct new product development, design transfer, process development, as well as sustaining changes within current Design Controls maintained by Teleflex policies and procedures. This position provides design-level direction to operations projects which require R&D oversight. The position ensures projects are prioritized and resourced for timely completion, utilizing creative solutions when issues arise. The Sr. Manager, Asia Region AEM R&D position includes direct management of the R&D teams in both Malaysia facilities and reports to the Director, Sustaining Engineering of the AEM Business Unit.

Principal Responsibilities

• Directs the teams responsible for research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms.
• Ensures staff prepares or coordinates formal documentation of the product Designs, Risk Analysis, Product Specifications, User Needs, etc. according to established Design Control Procedures, and initiates formal reviews and approvals.
• Accountable for remediation and updates of Design History Files, Technical Files or other product registration efforts as required.
• Responsible to ensure Design History Files and Technical Files created or modified are updated to current regulatory requirements.
• Ensures staff is trained to all current procedures and regulatory requirements required for successful performance of their positions.
• Coordinates the product design and development process with appropriate support departments such as engineering, quality, regulatory, documentation, global procurement and manufacturing.
• Assigns project leaders for projects and responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable. Prioritizes projects within the technical teams according to Business Unit priority.
• Ensures the R&D teams prepare accurate design drawings, specifications, estimates of costs, system updates, etc.
• Responsible to establish a culture of respect, trust and teamwork among the diferent Asia sites and with the different departments.
• Consults with marketing, sales, clinical, etc. on product requirements and specifications where design or manufacturing issues are involved.
• Ensures close collaboration with manufacturing in the justification and the selection of the manufacturing process and assigns projects and establishes priorities to ensure datelines and goals are achieved.
• Reports on Asia 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. Reports via electronic systems as appropriate.
• Enables the growth and development of technical staff by ensuring participation in education programs, professional development, industry conferences, current literature, training meetings and workshops.
• Leader and mentor for site-level managers and development engineers.
• Facilitates continuous quality and system improvement activities and best practice sharing across sites in Asia, US and internationally.
• Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
• Maintains compliance with principles of accepted employee conduct as identified in the Teleflex policies, procedures, and core values.
• Performs other related duties as assigned or requested.
• Travel required up to 25%

Education / Experience Requirements

• MS or BS degree in engineering or closely related field. Possession of specific degree may be substituted by equivalent work experience in the design and/or modification of plastic components for the medical industry
• Minimum of twelve (12) years of progressively responsible, professional engineering experience, with engineering lead capacity in the appropriate specialty. Medical Device, Pharmaceuticals or other highly regulated industry experience required.
• Experience in Injection molding, plastic extrusion and part assembly process/methods will be added advantage.
• Demonstrated success in the product development and launch of medical devices.

Specialized Skills / Other Requirements

• Ability to travel domestically and internationally. Ability to travel between Malaysia facilities frequently.
• Ability to coach and mentor managers, engineers and other professionals.
• Learns the strengths and interests of staff members to ensure work assignments are most efficiently distributed and managed while challenging engineers to grow and improve across all experience levels.
• Demonstrate creativity and ingenuity in applying engineering principles and practices. Draw solutions form a wider range of experience. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
• Very strong interpersonal and communication skills; proficient in leading teams as well as influencing cross-functionally resulting in the ability to gain alignment and drive consensus on project decisions.
• Analyze complex, technical and administrative problems and adopt an effective course of action. Excellent time management and capable of prioritizing for timely execution.
• Develop project and departmental budgets and schedules and provide monthly reporting.
• Conduct Personnel Evaluations for direct reports, recommend employee actions and development for direct reports.
• Speak and write English fluently.

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Teleflex is an equal opportunities employer

Teleflex is the home of Arrow\xc2\xae, Deknatel\xc2\xae, Hudson RCI\xc2\xae, LMA\xc2\xae, Pilling\xc2\xae, R\xc3\xbcsch\xc2\xae, UroLift\xc2\xae and Weck\xc2\xae - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, R\xc3\xbcsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

\xc2\xa9 2021 Teleflex Incorporated. All rights reserved.

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