Process Engineer
On-siteNorfolk, Virginia, United States
Job Summary
Develop, optimize, and maintain manufacturing processes for single-use supplies and medical device components while troubleshooting hardware, quality, and test issues to support production schedules. Provide corrective actions for tooling downtimes, conduct validation activities including IQ/OQ/PQ, and translate engineering designs into manufacturing operations, work instructions, and workflows. Design new equipment, fixtures, and tools; analyze production data for trends; and manage small-to-medium engineering projects from concept through execution. Disposition non-conforming materials, review drawings for manufacturability, and ensure compliance with FDA and ISO 13485 requirements. Drive continuous improvement using Lean and Six Sigma methodologies, train staff, and support new product introductions and process scale-up.
Required Qualifications
- Bachelor's degree in STEM
- minimum of 5 years of relevant work experience within the medical device or other regulated manufacturing environment
- Strong multidisciplined engineering aptitude, analytical skills and problem-solving skills
- Experience with Lean Manufacturing and Continuous Improvement activities
- Proficiency with CAD modeling tools
- Strong organization skills with the ability to manage multiple tasks simultaneously
- Proficient use of Microsoft Office suite (Excel, PowerPoint, Word
- strong knowledge of lean manufacturing, Six Sigma, and statistical process control (SPC)
- experience with validation protocols (IQ/OQ/PQ) and risk management tools (FMEA)
- solid company-centric ideology
- core values of honesty and respect
- a thirst for learning
- the desire to be challenged
- Applicants for this position must successfully pass background, drug screen and reference check
Desired Qualifications
- enjoy an autonomous work environment
- have a LEAN mindset
- are the first person to help
- seek out opportunities to bring added value
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.