Sr. Manufacturing Engineer - Endologix
Santa Rosa, CA 95403
About the Job
Overview:
Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
Responsibilities:- 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
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Has the ability to use moderate to advanced statistic techniques when analyzing data and make rational and logical decision base the that analysis
- Applicable knowledge of Minitab, JMP, or other statistic tools
- Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)
- May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Education:
- Requires a Bachelop of Science degree in Engineering or related technical degree (i.e. physics or mathematics)
Experience:
- Five years with a Bachelor's degree, Three years with a Master's degree of directly relevant
Compensation: $82,000 to $130,000.00 annual salary depeding on experience
Source : Endologix