Medical Device Product Development Engineer II

LifeSync Corporation; Florida; On-site; USD 85,000 - 115,000; Full time

Job summary

LifeSync Corporation seeks a Product Development Engineer II to lead technical execution in medical device development, verification, and lifecycle management. You will apply design controls, document specifications, and collaborate across Engineering, Manufacturing, Quality, and Regulatory affairs to ensure compliant product delivery.

The role emphasizes design verification, validation, DHF maintenance, and risk management, with close involvement in FDA/510(k) and EU MDR considerations as

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• Minimum 3 years of relevant engineering experience in a regulated setting.
• Experience applying engineering principles, data analysis, and structured problem solving to design decisions.
• Experience developing/test methods, analyzing data, and documenting conclusions.
• Knowledge of design controls, verification/validation, risk management, and engineering changes.

Responsibilities

• Execute engineering activities supporting new product development, modifications, and sustaining engineering.
• Apply engineering principles to evaluate designs, materials, processes, and performance.
• Develop design concepts, product specifications, drawings, BOMs, and technical documentation.
• Perform analyses including tolerance, trade-off, failure analysis, and test data interpretation.
• Maintain DHF and technical evidence, support verification/validation, and regulatory submissions as needed.
• Collaborate with cross-functional teams to support DFM, prototypes, process validation, and design transfer.
• Evaluate changes for impact on performance, manufacturing, quality, risk, and regulatory.

Skills

Analytical thinking

Structured problem solving

Cross-functional

Technical writing

Regulatory awareness

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

Job description

LifeSync Corporation seeks a Product Development Engineer II to lead technical execution in medical device development, verification, and lifecycle management. You will apply design controls, document specifications, and collaborate across Engineering, Manufacturing, Quality, and Regulatory affairs to ensure compliant product delivery.

The role emphasizes design verification, validation, DHF maintenance, and risk management, with close involvement in FDA/510(k) and EU MDR considerations as