Join our high-impact manufacturing team at Endologix as a Sr. Manufacturing Engineer! As a Sr. Manufacturing Engineer, you will be responsible for designing and developing manufacturing processes, tooling, and fixtures in order to meet daily production schedules, while enhancing productivity and product quality within endovascular and peripheral technologies.
Requirements
- Design and develop manufacturing processes for new products and/or changes to existing products.
- Design and develop fixtures and tooling for manufacturing process.
- Develop and execute process validation protocols (IQ/OQ/PQ).
- Analyze process data and make decisions/recommendations relating to process capability and DFM.
- Perform Installation Qualification (IQ) equipment protocols and reports.
- Investigate benefits and features of capital equipment and generate capital appropriation justifications.
- Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions.
- Provide engineering support to production department in troubleshooting and resolving technical problems.
- Contact and address component and/or raw material issues with suppliers.
- Support manufacturing and quality with addressing NCMR issues.
- Plan, schedule, and complete projects in a manner consistent with business objectives.
- Contribute to the intellectual property position of the company via invention and patent applications.
- Maintain accurate documentation of concepts, designs, and processes.
- Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
- Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
- Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved.
- Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- Ensure that all regulatory and internal policies are followed.
- Assist engineering manager in development of engineers providing assistance with coaching and mentoring.
- Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
- Perform other duties as assigned by supervisor.
Benefits
- Comprehensive health, dental, and vision insurance plans
- Generous PTO and holiday schedule
- 401(k) retirement plan with company match
