RESEARCH & DEVELOPMENT AND SUSTAINING ENGINEER

BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD.; Seberang Perai; On-site; MYR 180,000 - 320,000; Full time

Job summary

BACTIGUARD (South East Asia) Sdn. Bhd. announces a leadership role for an experienced R&D and Sustaining Engineer to guide a multi-disciplinary team through design, prototyping, testing and optimization of medical devices.

The successful candidate will manage budgets, coordinate cross-functional projects, ensure compliance with ISO 13485, MDR and FDA guidelines, and drive new product development while improving existing components for quality and cost efficiency.

Qualifications

• Bachelor degree in Engineering or Science or equivalent.
• Experience in medical devices and R&D management is required.
• Familiarity with ISO 13485, MDR, FDA 21 CFR Part 820 Design Control is advantageous.

Responsibilities

• Lead, oversee and manage all aspects of design, prototyping, testing, and improvements for NPD and sustaining projects.
• Manage CAPEX and OPEX budgets and forecast for AOP.
• Coordinate with stakeholders across Marketing, Sales, Clinicians and cross-functional teams.
• Ensure compliance with Design Control and QMS requirements.

Skills

Project management

Leadership

Medical devices

ISO 13485

Regulatory knowledge

Budget management

Cross-functional teamwork

Education

Bachelor degree in Engineering or Science

Job description

RESEARCH & DEVELOPMENT AND SUSTAINING ENGINEER

implement strategic product and development activities and provide leadership to Assistant Manager, R&D Staff Engineer, R&D Senior Engineer, R&D Engineer, Product Sustaining Engineer, Clinical Specialist, Packaging & Labelling Engineer and Design Assurance and Compliance Engineer.

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

Participate in Innovation activities for the New Product Development pipeline, including market research, concept generation and development.

Liaise with Finance department for the financial planning and management including preparing budgeting for OPEX, CAPEX etc. Manage all aspects of the CAPEX and OPEX budgets throughout the financial forecasting process throughout the year and for Annual Operating Plan (AOP).

Lead workstream leads to ensure their team members’ project objectives are met per committed target dates. Establish roles and responsibilities to manage deliverables to meet business commitments.

Act as SME approver on all relevant quality system documentation related to product and design.

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 and timely resolution of issues

Interface with the Marketing Leaders, Product Managers, Sales Partners, Clinicians, and cross functional teams to establish design criteria for new products and product improvements.

Ensures all projects are executed to comply with Bactiguard Design Control and QMS requirements.

Maintains 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 relevant procedures, FDA, CE and industry guidelines.

Support technical file preparation, regulatory submissions and audits as required.

Review and conduct assessment of process, design verification and validation including approval when required.

Develops staffing requirements and works closely with HR on hiring, personal development plan and utilize appropriate performance management process to drive individual and team performance.

Document all new ideas for products and/or processes which should be assessed for intellectual property opportunity. Work with the legal team to file new patents and assess potential for infringement

Adhere to and ensure the compliance of all Company policies, rules, procedures ad housekeeping standards.

To ensure implementation and maintenance within the workplace of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.

POSITION SPECIFICATIONS

Minimum Bachelor Degree in an Engineering or Science discipline. Project Management or Six Sigma Greenbelt or Blackbelt qualifications would be a distinct advantage.

10+ years relevant industry experience preferably Medical Devices. 5+ years management responsibility of research & development or new technology development group Familiarity with ISO 13485, MDR, FDA 21 CFR Part 820 Design Control, ISO 14971, GMP and other standards as they relate to the development and manufacture of medical devices would be an advantage

Specialized skills/ technical knowledge:

Min 10 years in a technical position (product/process design) in Medical Device Industries

Strong skills in project and people management:

Good working knowledge of polymer materials including surface modifications and coating technologies, as well as their processing through moulding and extrusion

Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget

Develop a team that has advanced understanding of external and internal customers to effectively to improve design and quality products.

Previous experience in new technology and product strategy development and execution of research and development projects

Ability to delegate tasks and decisions ad set the expectations of responsibility and accountability.

Understanding and ability to adhere to established quality standards and regulatory compliance and Design Control requirements for medical device industry.

Strong analytical and problem –solving skills.

Effective written and verbal communication skills in English.

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• How many years' experience do you have in a Research and Development Role?
• Which of the following types of qualifications do you have?
• How many years of experience do you have in the Medical Device Industry?

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.

To help fast track investigation, please include here any other relevant details that prompted you to report this job ad as fraudulent / misleading / discriminatory / salary below minimum wage.

Researching careers? Find all the information and tips you need on career advice.