R&D Manager Tracheostomy

Teleflex; Kamunting; On-site; MYR 120,000 - 160,000; Full time

Job summary

A global provider of medical technologies is seeking an experienced R&D Manager to drive Tracheostomy Research & Development activities. The ideal candidate will hold an Honors Degree in Engineering or Science and possess over 10 years of relevant industry experience, along with at least 3 years in management. This leadership role involves overseeing design processes, managing project teams, and ensuring compliance with regulatory standards, making a significant impact on healthcare outcomes in Kamunting, Malaysia.

Qualifications

• 10+ years of relevant industry experience, preferably in Medical Devices.
• 3+ years of management responsibility in research & development or new technology development groups.

Responsibilities

• Implement strategic Tracheostomy Research & Development activities.
• Lead and manage design, prototyping, and testing processes.
• Liaise with Finance for R&D financial planning.
• Establish roles and deliverables for project teams.
• Communicate with key stakeholders on project alignment.
• Interface with cross-functional teams to establish design criteria.
• Maintain consistent engineering practices and documentation.
• Ensure compliance with SOPs, FDA, CE and industry guidelines.

Skills

Leadership

Project Management

Technical Expertise

Communication

Regulatory Compliance

Education

Honors Degree in Engineering or Science

Project Management Qualification

Job description

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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. 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

• To implement strategic Tracheostomy Research & Development activities for R&D Kamunting and provide leadership to R&D Assistant Manager, Staff R&D Engineer, Senior R&D Engineer, Senior R&D Compliance Engineer, Engineer(s) and support functions.
• Lead, oversee and manage all aspects of the design, prototyping, testing (verification and validation), the redesigning and improving existing components, and continually searching for improved quality and cost efficiency in all NPD and Sustaining projects, as well as C2C and Sustaining business processes.
• Liaise with Finance department for the R&D Tracheostomy financial planning and management including preparing budgeting for OPEX, CAPEX, etc.
• Lead project team members to meet project objectives and target dates. Establish roles and responsibilities to manage deliverables to meet business commitments.
• Communicate effectively with key stakeholders on a regular basis to ensure alignment on project baseline (scope, schedule, and budget). Collaborate with project managers on execution of project deliverables and mitigation of risks.
• Interface with the Marketing Leaders, Product Managers, Sales Partners, Clinicians, and cross-functional teams to establish design criteria for new products and product improvements.
• Determine the implementation of internal product development processes (e.g. Structured Design Process) and assess conformance and impacts to development time and cost.
• Maintain consistent engineering practices, standards, documentation procedures including design history file, and act as a subject matter expert with regards to the relevant product portfolio. Identify technical training and development plans. Maintain leadership and technical capabilities through continued education or training.
• Lead the team in interpreting complex technical requirements, managing associated risks throughout the development cycle, completing technical studies and design reviews. Ensure compliance to all SOPs, FDA, CE and industry guidelines.
• Support regulatory submissions and clinical trials as required.
• Review and conduct assessment of process, design verification and validation including approval when required.
• Develop staffing requirements and work closely with HR on hiring, personal development plan and utilize appropriate performance management process to drive individual and team performance.
• Adhere to and ensure the compliance of all Company policies, rules, procedures and housekeeping standards.
• Ensure implementation and maintenance within the workplace of an effective management system for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.

Education / Experience Requirements

Qualification

Honors Degree in an Engineering or Science discipline.

Project Management qualification would be a distinct advantage.

Experience

10+ years of relevant industry experience, preferably in Medical Devices

3+ years of management responsibility in research & development or new technology development groups

Specialized Skills / Other Requirements

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.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.