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