Onsite Process Engineer — Lean Six Sigma (Medical Devices)

BioHorizons; Hoover (AL); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical plans

HSA/FSA

Dental insurance

Wellness program

401(k) with matching

Generous PTO

Disability insurance

Life insurance

Casual dress code

Job summary

BioHorizons seeks a Vulcan Process Engineer in Hoover, AL to drive manufacturing improvements and sustain compliant production. You will collaborate with cross-functional teams and management to optimize processes, support new product introductions, and ensure audit readiness in a regulated environment.

The role requires a Bachelor's in engineering, 4+ years in FDA/ISO medical device manufacturing, and hands-on Lean/Six Sigma, root-cause analysis, and project leadership.

Qualifications

• Bachelor’s degree in engineering or related field.
• 4+ years’ experience in FDA/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.

Responsibilities

• Drive improvement projects and coordinate cross-functional efforts to achieve project success.
• Identify challenge areas and gaps for process improvement/waste reduction.
• Use Lean and Six Sigma techniques to eliminate process waste.
• Develop, evaluate, and improve manufacturing processes for existing and new products.
• Support engineering initiatives in analyzing production processes for repeatability and efficiency.
• Contribute process knowledge to process validation (IQ, OQ, PQ).
• Generate and maintain SOPs for updated or new processes.
• Assist in audits and ensure audit readiness; support first-, second-, and third-party audits.
• Communicate project statuses and updates with the team.
• Facilitate training for process changes with management.
• Onboard new products with Vulcan management and other departments.
• Develop and analyze KPIs for process evaluation and forecasting for growth and capacity planning.

Skills

Communication skills

Attention to detail

Initiative

Planning and organization

Project management

Initiative and accountability

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Job description

BioHorizons seeks a Vulcan Process Engineer in Hoover, AL to drive manufacturing improvements and sustain compliant production. You will collaborate with cross-functional teams and management to optimize processes, support new product introductions, and ensure audit readiness in a regulated environment.

The role requires a Bachelor's in engineering, 4+ years in FDA/ISO medical device manufacturing, and hands-on Lean/Six Sigma, root-cause analysis, and project leadership.