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 $130,000.00 annual salary depeding on experience