Job Description
Join our dynamic team at Sabio Advisory Corporation as a Project Engineer specializing in Medical Device manufacturing. This exciting opportunity is perfect for a technical professional passionate about healthcare innovation and quality-driven engineering.
In this role, you will be at the forefront of medical device contract manufacturing, supporting critical projects that directly impact patient safety and healthcare outcomes. You'll work within a regulated environment adhering to ISO 13485 standards and Quality System Regulation (QSR) requirements, ensuring all processes meet the highest quality benchmarks.
This position offers excellent exposure to validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), making it ideal for engineers seeking to deepen their expertise in medical device quality assurance. You'll collaborate with cross-functional teams to deliver projects on time while maintaining compliance with Singapore's stringent regulatory framework.
If you're looking to advance your career in a growing industry that combines engineering excellence with healthcare impact, this role provides the perfect platform for professional development and career progression.
Responsibilities
- Lead and coordinate medical device manufacturing projects from initiation to completion, ensuring adherence to timelines and quality standards
- Develop and execute validation protocols including IQ/OQ/PQ documentation for manufacturing processes and equipment
- Ensure compliance with ISO 13485 quality management system requirements and regulatory guidelines
- Collaborate with quality assurance teams to maintain documentation and quality records in accordance with QSR
- Conduct risk assessments and implement corrective actions to address non-conformances
- Interface with clients and stakeholders to provide technical updates and project status reports
- Optimize manufacturing processes to improve efficiency and reduce costs while maintaining quality
- Support internal audits and regulatory inspections as required
Qualifications
- Bachelor's degree in Engineering, Biomedical Engineering, or a related technical discipline
- Minimum 2 years of experience in medical device or pharmaceutical manufacturing environment
- Working knowledge of ISO 13485, FDA QSR, and Singapore regulatory requirements
- Hands-on experience with IQ/OQ/PQ validation protocols and documentation
- Strong analytical and problem-solving abilities with attention to detail
- Excellent communication skills with the ability to work effectively in a team environment
- Proficiency in Microsoft Office applications and quality management software
- Certification in quality or validation (e.g., ASQ, CIT) would be advantageous