Product Engineer

Job Description

Job Description

Position Summary

We are seeking a talented Product Development Engineer to support the design, development, and continuous improvement of innovative medical products. This role will be responsible for translating customer and clinical needs into engineered solutions while ensuring products meet quality, manufacturing, regulatory, and performance requirements. The ideal candidate will have a strong engineering foundation, experience with product development processes, and a passion for creating high-quality products that improve patient outcomes.

Key Responsibilities

• Support the design, development, verification, and implementation of new products and product enhancements.
• Provide technical expertise for existing products, including quality improvements, manufacturing support, supply continuity, and cost-reduction initiatives.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, and Supply Chain.
• Gather and analyze customer and user needs through market research, clinical observations, customer interviews, competitive analysis, and product evaluations.
• Translate customer requirements into detailed engineering specifications, product designs, packaging requirements, and manufacturing processes.
• Apply engineering principles to develop robust, reliable, and manufacturable product solutions.
• Design and execute engineering tests, including development of test methods, equipment selection, test setup design, data collection, and statistical analysis.
• Analyze test results and prepare technical reports to support product development, design changes, and validation activities.
• Participate in project planning and execution to ensure successful completion of technical and cross-functional initiatives.
• Ensure compliance with applicable quality standards, regulatory requirements, and safety procedures.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 1-2 years of engineering experience, preferably within the medical device, healthcare, or regulated manufacturing industry.
• Solid understanding of engineering fundamentals, product development processes, and design verification activities.
• Experience developing and executing engineering tests and analyzing technical data.
• Proficiency with statistical analysis tools and computer-based engineering applications.
• Strong problem-solving, analytical, and communication skills.
• Ability to work effectively in a collaborative, team-oriented environment.

Preferred Qualifications

• Experience in medical device product development.
• Familiarity with design controls and regulated product development environments.
• Knowledge of manufacturing processes and product lifecycle management.
• Experience supporting design verification and validation activities.
• Exposure to quality systems and compliance requirements within regulated industries.