Product Engineer

About the Role

We are seeking a Product Engineer to join our medical device team. This role will be instrumental in the design, development, validation, and lifecycle management of safe and effective products that improve patient outcomes. The ideal candidate has strong technical expertise, hands-on engineering experience, and a passion for delivering innovative solutions in a regulated healthcare environment.

Key Responsibilities

• Lead product development activities from concept to commercialization, ensuring compliance with ISO 13485 and FDA standards.
• Prepare and execute design validation and verification protocols (DFMEA, risk analysis, reliability testing).
• Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing to bring new products to market.
• Develop and maintain technical documentation including design history files, BOMs, process charts, and engineering change orders.
• Perform prototype builds, material evaluations, and process validations to support continuous improvement and cost-effectiveness.
• Drive problem-solving and root cause analysis to resolve design, process, or product performance issues.
• Stay updated with the latest medical device regulations, standards, and technologies to ensure ongoing compliance and innovation.

Qualifications

• Bachelors degree in Mechanical, Biomedical, Electrical, or Industrial Engineering.
• Minimum 3-5 years of experience in product engineering, preferably in the medical device industry.
• Proficiency in CAD software (SolidWorks, AutoCAD, or equivalent).
• Solid understanding of ISO 13485, FDA 21 CFR Part 11/820, and risk management practices.
• Hands-on experience in DFMEA, DFM/A, validation testing, and product lifecycle management.
• Strong collaboration skills to work across multi-disciplinary teams.
• Excellent problem-solving, analytical, and documentation skills.