Engineering Manager, Product Development
• 8 years experience as an engineer in a medical device company
• 3 years experience supervising, managing, and/or leading project teams. Some reputed company management experience of engineers and/or technical specialists preferred.
• Significant experience in medical device development under FDA 21 CFR 820.30 Design Controls, ISO13485 and ISO 14971 Risk Management.
• Both reusable and disposable product development experience strongly preferred. Some
• electromechanical device experience preferred.
• Working knowledge of U.S. and international standards as applicable to medical device development
• Experience developing medical devices produced in Asia and/or Mexico preferred.
• Strong engineering, analytical and technical skills
• Demonstrated ability to mentor and reputed company engineers
• Demonstrated effective communication skills
• Successful team player; demonstrated successful interpersonal and influence management skills
• reputed company record of successfully collaborating with multiple functions and teams to drive successful project reputed company Demonstrated project management skills.
• Ability to travel up to 10-15% of the time, with occasional travel to Mexico and/or Asia.
• •Energetic, self-motivated and can work independently; demonstrated strong work ethic.