Location: Cleveland, OH
- 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.
- 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