Impactful Process Engineer - Lean Six Sigma for Medical Devices

BioHorizons; Hoover (AL); On-site; USD 75,000 - 105,000; Full time

Job summary

BioHorizons in Hoover, AL seeks a Process Engineer to optimize manufacturing processes, lead cross-functional improvement projects, and support a compliant, efficient production environment. The role emphasizes Lean and Six Sigma methods, process validation activities, and ongoing SOP updates. The candidate should have a Bachelor’s in engineering and 4+ years in FDA/ISO-regulated medical device settings, including 2+ years with medical device workflows.

Qualifications

• Effective communication and facilitation skills required.
• High degree of initiative and accountability.
• Strong planning and organizational skills required.

Responsibilities

• Drive improvement projects with cross-functional teams.
• Identify gaps for process improvement and waste reduction.
• Apply Lean and Six Sigma to remove process waste.
• Develop and improve manufacturing processes for existing and new products.
• Support process validation (IQ, OQ, PQ).
• Generate and maintain SOPs for updated processes.
• Maintain audit readiness and assist audits.
• Communicate project statuses to the team.
• Facilitate training on process changes.
• Forecast growth and capacity planning.

Skills

Communication

Attention to detail

Initiative

Planning & organizing

Project management

Education

Bachelor’s degree in engineering

Job description

BioHorizons in Hoover, AL seeks a Process Engineer to optimize manufacturing processes, lead cross-functional improvement projects, and support a compliant, efficient production environment. The role emphasizes Lean and Six Sigma methods, process validation activities, and ongoing SOP updates. The candidate should have a Bachelor’s in engineering and 4+ years in FDA/ISO-regulated medical device settings, including 2+ years with medical device workflows.