Process Engineer - Vulcan

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Process Engineer - Vulcan

Regular Full-Time Hoover, AL, US

7 days ago Requisition ID: 1977

The Vulcan Process Engineer influences the company’s direction with respect to production. This position works with all departments and Vulcan management to evaluate current processes with respect to continuous improvement to keep production running smoothly. Works with Vulcan managers/supervisors to optimize organizational business performance by maintaining compliance with domestic quality system regulations.

Essential Duties and Responsibilities:

• Responsible for driving improvement projects and coordinating efforts between a cross-functional team, with both internal and external stakeholders to achieve project success.
• Works with management to identify challenge areas and key gaps within organization for process improvement/ waste reduction projects.
• Utilize Lean and Six Sigma techniques to identify and eliminate process waste throughout the system.
• Develop, evaluate, and improve manufacturing processes for existing and new products.
• Support Engineering initiatives in analyzing the production process for repeatability and efficiency.
• Contributes process knowledge to developing and executing process validation efforts (IQ, OQ, PQ).
• Generate and maintain SOPs as needed for updated or new processes.
• Help to maintain audit readiness and assist in first-party, second-party and third-party audits.
• Communicate statuses and updates with team for all assigned projects.
• Works with management team to facilitate training for process changes.
• Works with all departments and Vulcan management to facilitate the onboarding of new products.
• Develop, analyze, and maintain key performance indicators for process evaluation.
• Develop and analyze forecasting to predict growth and capacity planning.

Qualifications:

• Effective communication and facilitation skills required.
• Strong detail on detail and accuracy.
• High degree of initiative and self-motivation with a strong sense of accountability.
• Outstanding planning and organizational skills and techniques required.
• Ability to plan and manage complex and successful projects; understand available resources, develop a timeline, budget and assign areas of responsibility.

Education and/or Experience:

• Bachelor’s degree in an engineering-related field and/or an equivalent combination of education/experience
• 4+ years’ experience working at an FDA and/or ISO regulated medical device manufacturer.
• Minimum of 2 years' experience working with medical device workflows.