Process Engineer - Vulcan

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

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

18 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.

This position is onsite based in Hoover, AL and is not open to remote work.

We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.

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.
• Experience in facilitating cross-functional teams; overseeing root-cause analysis, data collection, and problem solving.
• 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
• Flexible Spending Account or HSA Account available
• Company paid Dental Insurance for employee and dependents
• Wellness Plan
• 401k with 5% matching
• Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
• Company paid Short Term Disability
• Long Term Disability
• Company provided Life Insurance
• Casual Dress Code
• Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.