Pay 50-53/h depending on experience Product Development & Engineering • Lead end-to-end product development activities including design, prototyping, testing, and validation • Drive technical decisions and provide engineering expertise throughout the product lifecycle • Develop and review engineering specifications, design documents, and technical reports • Identify and resolve complex engineering challenges using systematic problem-solving approaches • Cross-Functional Collaboration • Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment • Serve as a technical resource and mentor for junior engineers • Communicate technical concepts clearly to both technical and non-technical stakeholders • Project Leadership • Lead or contribute to multiple concurrent engineering projects • Define project scope, timelines, and deliverables • Track milestones and proactively manage risks and dependencies Quality & Compliance • Ensure products meet regulatory requirements (e.g., ISO, FDA, MDR) and internal quality standards • Support design verification and validation (V&V) activities • Participate in design reviews, FMEAs, risk assessments, and change control processes • Continuous Improvement • Identify opportunities to improve products, processes, and engineering practices • Apply data-driven methods to analyze performance and drive decisions • Stay current with industry trends, emerging technologies, and best practices Requirements: • B.S. in Mechanical, Electrical, Biomedical, or related Engineering field • * Bachelor’s degree or higher in Life Sciences or related discipline • * Minimum 5-7 years of experience in Quality Assurance and/or Quality Systems within the medical device industry. • * Experience implementing or improving ISO 13485-based QMS. • * Strong experience working with Singapore medical device regulatory requirements. • * Demonstrated experience supporting or leading GDPMDS/GDP certification projects. • * Proven track record of successfully helping organizations obtain and maintain GDP certification • * Experience interacting with certification bodies, accreditation bodies, and regulatory authorities. Technical skills: • 5-8+ years of product engineering experience • Validation experience, design analysis, V&V testing, PLM, Design Controls, ISO 13485, FDA 21 CFR Part 820