Design Engineering Manager

Cleveland, OH     ·       Full time

Location: Cleveland, OH

Responsibilities

• Lead Design Engineering resources to sustain existing products and drive product improvements.
• Define Design Engineering objectives and manage towards completion of objectives.
• Support the Quality Management System (QMS) and related Design Engineering responsibilities, including
• Ensure products meet customer, company, and regulatory requirements.
• Develop and manage design engineering project budgets and timelines, communicating progress across the organization.
• Oversee the maintenance of product Design History Files (DHF) and the creation of the Device Master Record (DMR).
• Perform analysis and establish test plans to demonstrate products meet all requirements.
• Contribute to New Product Development by managing the Design Engineering resources needed to support the development team.
• Provide technical support for the Sales Team, customers, and clinical trial sites as needed.
• Support the design transfer to manufacturing.
• Contribute to project team activities as assigned.     

Requirements:

• Bachelor’s Degree in Engineering discipline (Mechanical, Electrical, Biomedical, or related field).
• Minimum 7 years of experience with FDA/GMP regulated medical device development and manufacturing to include a minimum of 2 years of Engineering management experience.
• Project management including planning, execution, and meeting time and budget constraints.
• Proficient with medical device DHF and DMR files management and documentation requirements.
• Experience managing medical device development, design transfer, design for manufacturability (DFM), improving reliability and reducing product cost.
• Understanding and experience with FDA regulations and design control requirements

Why Join Our Team?

• Entrepreneurial work environment – A growth oriented and collaborative atmosphere in the medical device industry!
• Ability to work with game changing technology
• Competitive compensation and benefits
• Employee Wellness Program

Please click here to learn more.