Job Opportunity for Medical Device Engineer, in Warsaw IN

I’m reaching out regarding a Product Development / Design Controls Engineer opportunity in the medical device industry.

Key Responsibilities:

• Support design controls, risk management, and integration of acquired medical device technologies.

• Prepare and review technical protocols, procedures, and regulatory documentation.

• Support product development, design changes, and manufacturing transfers.

• Coordinate with cross-functional teams on project plans, risks, timelines, and deliverables.

Required Skills:

• Bachelor’s degree in Engineering with 3 years of relevant experience.

• Experience in medical device product development and design controls.

• Knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.

• Understanding of risk management, technical documentation, and regulatory compliance.

• Knowledge of statistical methods, DOE, and Minitab is preferred.