Position Summary

Principal Responsibilities

1. 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.
2. 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.
3. Liaise with Finance department for the R&D Tracheostomy financial planning and management including preparing budgeting for OPEX, CAPEX, etc.
4. Lead project team members to meet project objectives and target dates. Establish roles and responsibilities to manage deliverables to meet business commitments.
5. 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.
6. Interface with the Marketing Leaders, Product Managers, Sales Partners, Clinicians, and cross-functional teams to establish design criteria for new products and product improvements.
7. Determine the implementation of internal product development processes (e.g. Structured Design Process) and assess conformance and impacts to development time and cost.
8. 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.
9. 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.
10. Support regulatory submissions and clinical trials as required.
11. Review and conduct assessment of process, design verification and validation including approval when required.
12. 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.
13. Adhere to and ensure the compliance of all Company policies, rules, procedures and housekeeping standards.
14. 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