job description
Are you a seasoned Programme Manager with expertise in CDMO (Contract Development and Manufacturing Organization) product development for regulated MedTech products? Join RecruitPedia Pte Ltd in a dynamic role where you will lead cross-functional teams to deliver cutting-edge microfluidics and reagent integration solutions. This position offers a unique opportunity to work in Baliās thriving tech and healthcare ecosystem while driving innovation in medical technology.
As a Programme Manager, you will oversee the entire product development lifecycle, ensuring compliance with regulatory standards and optimizing processes for efficiency. Your expertise in tolerance analysis and microfluidics will be pivotal in advancing our portfolio of medical devices. If you thrive in a collaborative environment and are passionate about transforming healthcare through technology, this role is for you.
We offer a competitive salary, flexible work arrangements, and the chance to make a tangible impact in the MedTech industry. Apply now to be part of a forward-thinking team in one of the worldās most inspiring locations.
Responsibility
- Lead end-to-end product development programmes for regulated MedTech products, ensuring adherence to CDMO standards.
- Oversee microfluidics and reagent integration projects, coordinating with engineering, R&D, and quality assurance teams.
- Conduct tolerance analysis to optimize product performance and manufacturability.
- Develop and maintain project timelines, budgets, and resource allocation plans.
- Ensure compliance with ISO 13485, FDA, and other regulatory requirements throughout the development process.
- Collaborate with external partners, including suppliers and contract manufacturers, to streamline production.
- Identify risks and implement mitigation strategies to ensure on-time, high-quality deliverables.
- Drive continuous improvement initiatives to enhance product development efficiency and innovation.
Qualifications
- Bachelorās or Masterās degree in Engineering, Biomedical Sciences, or a related field.
- Minimum 5 years of experience in programme management within the MedTech or CDMO industry.
- Proven expertise in microfluidics, reagent integration, and tolerance analysis.
- Strong knowledge of regulatory standards (ISO 13485, FDA, CE) for medical devices.
- Excellent project management skills, with experience using tools like MS Project, JIRA, or Agile methodologies.
- Exceptional communication and stakeholder management abilities.
- Ability to work in a hybrid or remote setting, with occasional travel to Bali-based offices.
- PMP, PRINCE2, or other relevant certifications are a plus.