Endotronix - Naperville, IL
posted about 2 months ago
Full-time - Senior
Naperville, IL
Miscellaneous Manufacturing
About the position
The Senior Manufacturing Engineering Manager at Endotronix is responsible for leading a team in the development, control, and validation of manufacturing processes for medical devices. This role focuses on enhancing product performance and yield, ensuring compliance with regulatory standards, and driving process improvements through data analysis and team collaboration.
Responsibilities
- Lead direct and/or indirect reporting individuals on team-based or project-based activities and goals.
- Support process development activities to account for design changes and performance improvements.
- Oversee in-house manufacturing through the development and execution of production documentation.
- Participate in CAPA investigations and NCR resolutions.
- Gather, organize, and analyze data related to manufacturing processes.
- Train personnel on production procedures and best practices.
- Author and maintain risk documentation for manufacturing processes.
- Perform Design Transfer activities to manufacturing, including Process Validation.
- Acquire and validate capital equipment for manufacturing.
- Troubleshoot equipment issues hands-on.
- Develop and track metrics to drive process improvements.
- Write and execute Process Validation of Equipment and Manufacturing Processes.
- Design and fabricate test fixtures for manufacturing and inspection purposes.
- Perform Test Method Validation of inspections, including Gage R&R analysis.
- Interact with vendors and suppliers to ensure timely completion of deliverables.
Requirements
- 5-10 years of medical device engineering experience preferred.
- Experience managing a multidisciplinary engineering team.
- Experience leading design/process engineering projects from development to completion.
- Working knowledge of ISO and FDA guidelines and requirements.
- Demonstrated ability to work independently with minimal supervision.
- Excellent oral and written communication skills, particularly in technical writing and documentation.
- Demonstrated organizational, interpersonal, and critical thinking skills.
- Strong background in mechanical or electrical design.
- Experience with statistical data analysis.
- Experience with SolidWorks, Minitab, Labview, MATLAB preferred.
- Proficiency with Microsoft Office Suite.
- Risk analysis experience (PFMEA, DFMEA, etc.).
Nice-to-haves
- Experience with digital healthcare solutions.
- Familiarity with data-driven decision-making processes.
Benefits
- Competitive compensation package
- Comprehensive benefits including unlimited PTO
- Opportunities for career growth and development
