Description

You will design and support procedure pack products for medical applications within a regulated environment.

Responsibilities

• Develop design solutions for Class II disposable medical devices that meet product requirements.
• Optimize designs for producibility, reliability, and cost-effectiveness.
• Create design test methodologies and performance specifications to verify functionality.
• Lead troubleshooting efforts through engineering analysis and data-driven problem solving.
• Manage project plans and deliverables using MS Project to meet established deadlines.

Required Skills

• 5+ years of experience in medical device design and development.
• Hands-on experience with Class II disposable devices in an FDA regulated environment.
• Proficiency with Pro/E for design development.
• Expertise with Minitab for statistical analysis.
• Application of DMAIC and Lean Sigma methodologies.
• Knowledge of ISO 13485, GMP, and medical device manufacturing requirements.
• Experience with statistical methods including DOE, SPC, MSA, ANOVA, t-test, and regression analysis.

Preferred Skills

• Experience interfacing with suppliers and manufacturing facilities to resolve design issues.

Key Skills

Education

Any Graduate