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Company Contact Info
- Dubuque, IA
- Tim Borop
- Phone: 262-886-8000x218
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PointOne Recruiting Solutions • Dubuque, IA
Posted 27 days ago
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Engineering Manager-Medical Devices
Are you ready for a new challenge, and motivated to make an impact at a leading, global, full-service medical device manufacturer with a reputation for developing products of quality and precision for nearly 50 years? If you would like to grow your career and fill an important position, then you could be what our client is looking for in their next Engineering Manager-Medical Devices. You will be responsible for approving new products and design changes in accordance with customer needs and regulatory requirements, as well as assisting in customer complaint investigations and initiating corrective/preventative action. Strong experience with FDA remediation and recall activities within large pharmaceutical/medical device industry is highly preferred. This is an excellent opportunity with a respected and stable company that offers a competitive compensation package. If this is for you or someone you know, please forward a current resume to email@example.com
Responsibilities – Engineering Manager
• Provides leadership to Product Engineers and manages assignment of responsibilities
• Manages customer product inquiries, product changes, and new product development
• Develops procedures to be compliant with regulatory requirements
• Reviews and approves Document Change Orders (DCO)
• Evaluates design or manufacturing problems and initiates process improvements
• Writes process validation protocols and results
• Assists in investigating and answering customer complaints
• Reviews and approves part specifications
• Approves new drawings and BOM’s
• Estimates and initiates solutions to reduce product costs
• Participates in maintaining the company’s quality system and adheres to standard operating procedures as applicable
Requirements – Engineering Manager
• Bachelor of Science degree in Engineering or related degree with at least 7 years work experience in Engineering
• Supervision experience preferred
• FDA remediation and recall exposure experience
• Understanding of ISO 13485 and FDA medical device regulations required
• Excellent written and oral communication skills required
• Possess ability to effectively delegate, motivate, and manage all functions of the engineering department
• Strong leadership skills to supervise engineering personnel
• Ability to use Microsoft Office required; CAD preferred
Apply Now! Send resumes to firstname.lastname@example.org