Manufacturing Engineer

Overview:

Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality, Support new product transfers to manufacturing.

Responsibilities:

• Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.
• 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.
• Perform Installation Qualification (IQ) equipment protocols and reports.
• Provide engineering support to production department in troubleshooting and resolving technical problems.
• Coordinate work with outside vendors, assigned technicians and tool room personnel.
• Plan and schedule projects in a manner consistent with corporate objective.
• 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.
• Provide engineering support to production department in troubleshooting and resolving technical problems.
• Work with new product development staff to ensure that new manufacturing processes are designed for manufacturability, help resolve issues.
• Maintain GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
• Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, etc.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Ensure that all regulatory and internal policies are followed.
• Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
• Perform other duties as assigned by supervisor

Qualifications:

• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
• Utilizes Solid Works drafting skills when appropriate

Education:

• Requires a Bachelor degree or equivalent in engineering or related discipline.
• Masters preferred

Experience:

• Requires a minimum of 2 years related experience.