Lean Six Sigma Process Engineer – Medical Devices

BIOHORIZONS IMPLANT SYSTEMS; Hoover (AL); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Medical insurance (2 plans)

Dental insurance

Wellness plan

401k with 5% matching

PTO and holidays

Short/Long term disability

Life insurance

Casual dress code

Social events

Job summary

BIOHORIZONS IMPLANT SYSTEMS in Hoover, AL is seeking a Process Engineer (Vulcan) onsite to drive continuous improvement across manufacturing. You will lead cross-functional projects, apply Lean and Six Sigma, develop and validate processes, maintain SOPs, and support audits.

A Bachelor’s degree in engineering with 4+ years in FDA/ISO medical device environments is required, with experience in manufacturing workflows and root-cause analysis.

Qualifications

• Bachelor’s degree in engineering or related field.
• 4+ years of experience in FDA and/or ISO regulated medical device manufacturing.
• Minimum 2 years' experience with medical device workflows.
• Experience facilitating cross-functional teams; root-cause analysis, data collection and problem solving.
• Familiar with Lean and Six Sigma concepts and project execution.

Responsibilities

• Drive improvement projects and coordinate cross-functional teams to ensure project success.
• Identify gaps and opportunities for process improvement and waste reduction.
• Apply Lean and Six Sigma to eliminate waste across the production system.
• Develop, evaluate, and improve manufacturing processes for existing and new products.
• Support process validation activities (IQ, OQ, PQ) and SOP development.
• Assist in audits and maintain audit readiness and documentation.

Skills

Effective communication

Attention to detail

Initiative & accountability

Planning & organization

Project management

Education

Bachelor’s degree in engineering

4+ years FDA/ISO medical device manufacturing

2+ years medical device workflows

Job description

BIOHORIZONS IMPLANT SYSTEMS in Hoover, AL is seeking a Process Engineer (Vulcan) onsite to drive continuous improvement across manufacturing. You will lead cross-functional projects, apply Lean and Six Sigma, develop and validate processes, maintain SOPs, and support audits.

A Bachelor’s degree in engineering with 4+ years in FDA/ISO medical device environments is required, with experience in manufacturing workflows and root-cause analysis.