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, 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 the 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 objectives.
• Contribute to the intellectual property position of the company via invention and patent applications.
• 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.
• 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.
• Identify hazards and mitigate 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 2-3 years related experience.

Compensation

$63,000 to 106,000 depending on experience. This position is eligible for a discretionary bonus and equity.