As a Senior NPI Quality Engineer, you will serve as the technical quality owner for active metal additive product lines. You will drive process validations (IQ/OQ/PQ), establish Statistical Process Control (SPC) frameworks, oversee mechanical and metallurgical testing, and partner with R&D and operations to transition products from development into scalable production.
Key Responsibilities
Develop and execute process validation protocols (IQ/OQ/PQ) and implement Statistical Process Control (SPC) to monitor build stability and Cpk.
Lead cross-functional root-cause investigations for complex product and process defects; enforce effective CAPA implementation using 8D methodologies.
Establish and validate mechanical and metallurgical testing protocols (tensile, density, hardness, microstructural evaluation) for titanium alloys (Ti-6Al-4V) and high-temp metals.
Own and maintain key quality records including Device Master Records (DMR), Engineering Change Orders (ECOs), and Failure Mode and Effects Analysis (FMEA).
Verify incoming raw material quality (e.g., metal powder lot chemistry and particle size distribution) prior to build release, and partner with customer teams to execute First Article Inspection (FAI) milestone approvals.
Qualifications
4+ years of quality engineering experience in advanced manufacturing or metal additive manufacturing environments.
Bachelor’s degree in Mechanical Engineering, Materials Science, Quality Engineering, or related technical field.
Strong command of process validation (IQ/OQ/PQ), SPC, 8D root-cause tools, GD&T, and metallurgical/mechanical testing methods.
Working knowledge of ISO 9001, AS9100, or ISO 13485 quality management systems and engineering change management.
Preferred Qualifications
Direct experience with titanium alloys (Ti-6Al-4V) in Laser Powder Bed Fusion (LPBF) or additive manufacturing workflows.
ASQ certifications (CQE, CRE) or Six Sigma Green/Black Belt certification.
VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match.
The annual base salary range for this position is $96,000 to $132,000.
Numbers & Facts
Location
Devens
Skills
8Dunmatched
AS 9100unmatched
Additive Manufacturingunmatched
American Society for Quality (ASQ)unmatched
Certified Quality Engineer (CQE)unmatched
Chemistryunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Engineeringunmatched
Engineering Change Managementunmatched
Engineering Change Orderunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
Geometric Dimensioning and Tolerancingunmatched
ISO (International Organization for Standardization)unmatched
ISO 9001unmatched
Material Scienceunmatched
Mechanical Engineeringunmatched
Mechanical Testingunmatched
Metal Manufacturingunmatched
Metallurgyunmatched
Process Developmentunmatched
Process Validationunmatched
Product/Service Launchunmatched
Quality Assurance Methodologyunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Record Keepingunmatched
Research & Development (R&D)unmatched
Root Cause Analysisunmatched
Scalable System Developmentunmatched
Six Sigma Black Beltunmatched
Six Sigma Green Beltunmatched
Statistical Process Controlunmatched
Systems Engineeringunmatched
Validation Planunmatched
eCosunmatched
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