Principal Manufacturing Process Engineer
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Pendleton • South Carolina • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Assembly
About the role
- Support new product development/design transfer by leading process development and validation
- Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost
- Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly, packaging, data collection, and process efficiency
- Draft and execute validation protocols and reports (IQ,OQ/PQ) for manual assembly and mechanized processes
- Lead the design, development, and commercialization of new equipment
- Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts
- Design, develop, and manage tooling and fixtures
- Assess and execute validation requirements accordingly
- Lead process improvement projects through Designed Experiments (DOE’s), structured problem solving (Lean A3, Six Sigma DMAIC), and Statistical Analysis
- Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques
Requirements
- B.S. in Engineering required; preferably in Mechanical, Electrical, Chemical, or Computer Engineering
- Minimum of 12 Yrs. experience in Design and Development or Manufacturing Engineering required
- Proven Experience leading process improvement projects
- Proven Experience leading new equipment, capital projects
- Experience leading/supervising direct reports
- Experience in medical device manufacturing or other health sciences industry preferred
- SAP, miniTab, Solidworks experience preferred
- Lean Six Sigma Green Belt / Black Belt certification preferred
- Expert knowledge of Materials and relevant Machine design/function
- Proficiency in Industry Standard (ASTM) Test Methods
- Proficiency in compliance with ISO regulations and FDA 21 CFR Part 820
Benefits
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Medical Clinics
- Free Onsite Lunch
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
process developmentvalidation protocolsdesign experimentsstatistical analysistooling designmechanized processesmanual assemblyMaster Validation StrategiesMaster Validation Planscompliance with ISO regulations
Soft skills
leadershipproblem solvingcommunicationproject managementteam managementcontinuous improvementoperational excellencequality enhancementcollaborationvendor negotiation
Certifications
Lean Six Sigma Green BeltLean Six Sigma Black Belt