Senior R&D Manager

Date: 01-Sep-2021

Location: Kulim, 02, MY

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4614

 

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

This position is responsible for all the Kulim R&D and Sustaining Engineering functions for the AEM BU. This position is responsible to manage new product development, design transfer, process development, as well sustaining changes within current Design Controls maintained by Teleflex policies and procedures. This position provides design-level support to operations projects which require R&D oversight. The position organizes and manages multiple projects to ensure timely completion, utilizing creative solutions when issues arise. The Sr. Manager position includes direct management of Development, Sustaining, Process and/or Tooling Engineers, and the R&D Laboratory.  Position may also be responsible for individual project management. The incumbunt must develop strong inter-departmental relationships. Ability to be an individual contributor, and act as technical lead if necessary while managing direct reports, project teams and R&D laboratory efforts effectively.

Principal Responsibilities

  • Conducts 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 to get approved per procedures.
  • Responsible 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 are current to current regulatory requirements.
  • Ensures staff is trained to all current procedures and regulatory requirements required 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 engineering, quality, regulatory, documentation, global procurement and manufacturing.
  • Assigns project leaders for assigned projects and 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 sales, clinical, etc. on product requirements and specifications where design or manufacturing problems are involved.
  • Works 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.
  • 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. Reports via electronic systems as appropriate.
  • Enhances growth and development through participation in education programs, professional development, industry conferences, current literature, training meetings and workshops.
  • Mentor for junior level employees.
  • 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 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.
     

Education / Experience Requirements

•    Minimum of eight (8) years of progressively responsible, professional engineering experience, two (2) years of which shall have been in an engineering lead capacity in the appropriate specialty. Recent Medical Device Development and plastic part design experience is mandatory.
•    Possession of 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.
 

Specialized Skills / Other Requirements

  • CADD (design/drafting) program, to include SolidWorks Experience
  • Microsoft Office Suite, (Project, Word, Excel and Access) 
  • Injection molding, plastic extrusion and plastic part assembly process and methods experience
  • Basic Lab principles and operation
  • U.S. FDA GMP, International Regulations 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 and general plastic components.
  • Manage Development Engineers and Project Teams effectively
  • 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.
  • Effectively present information to senior managers, clients, customers, and the general public. Interface effectively with Operations Management to prioritize and support Plant Sustaining Efforts.
  • Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department. Analyze complex, technical and administrative problems and adopt an effective course of action. Conduct comprehensive studies and preparation of reports including recommendations.
  • Develop project and departmental budgets and schedules and provide monthly reporting.
  • Conduct Personnel Evaluations for direct reports, recommend employee actions 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®, 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.