Description

You will lead process development, equipment specification, and implementation within a manufacturing environment. This role is on-site.

Responsibilities

• Identify root causes of manufacturing failures using structured problem solving and implement fixes to prevent reoccurrence.
• Troubleshoot machine logic, electromechanical systems, and process controls.
• Execute design of experiments, validation, testing, and data analysis to drive continuous improvement.
• Create and revise manufacturing documents, including SOPs, validation protocols, risk assessments, and safety instructions.
• Resolve Quality Incidents and CAPA while providing process expertise for tooling and validation.

Required Skills

• Bachelor's degree (BS) in engineering or an equivalent combination of education and experience.
• Minimum 3 years of engineering experience in a manufacturing environment.
• Proficiency with CAD software, Database software, and Manufacturing software.
• Experience with Project Management software and Development software.
• Familiarity with various material testing and measuring methods.
• Ability to apply mathematical concepts including ANSI/AQL, probability, and statistics.
• Willingness to travel up to 25% of the time.

Preferred Skills

• Experience in GMP, FDA, ISO, or USDA regulated environments, specifically ISO 13485.
• Proficiency with statistical analysis software such as Minitab.

Key Skills

Education

Any Graduate