Sr. Manufacturing Engineer

4 weeks ago


Santa Rosa California, United States Endologix Full time
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

Qualifications:
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 $(phone number removed) annual salary depeding on experience

 



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