Senior NPI Quality Engineer, Consumer Technology

VulcanForms Inc.; Harvard (MA); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

401(k) with company match

Job summary

VulcanForms Inc. is seeking a Senior NPI Quality Engineer to own the technical quality of active metal additive product lines. You will drive IQ/OQ/PQ validations, establish SPC, and oversee mechanical/metallurgical testing for Ti-6Al-4V and high-temp metals.

Collaborate with R&D and operations to scale from development to production. You will manage DMRs, ECOs, and FMEA, validate raw material quality, and support FAI milestone approvals with customer teams.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, Quality Engineering, or related field.
• Strong command of IQ/OQ/PQ, SPC, 8D, GD&T, and metallurgical/mechanical testing methods.
• Working knowledge of quality systems (ISO 9001/AS9100/ISO 13485) and engineering change management.

Responsibilities

• Develop and execute IQ/OQ/PQ validations and implement SPC to monitor build stability and Cpk.
• Lead cross-functional root-cause investigations and ensure CAPA using 8D methodologies.
• Establish and validate mechanical/metallurgical testing protocols for Ti-6Al-4V and high-temp metals.
• Own and maintain DMRs, ECOs, and FMEA.
• Verify incoming raw material quality and coordinate FAI milestone approvals.

Skills

Process validation

SPC

8D root-cause

GD&T

Metallurgical testing

Education

Bachelor’s degree in Mechanical Engineering / Materials Science / Quality Engineering

Tools

ISO 9001

AS9100

ISO 13485

Job description

Job Purpose

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.

VulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate’s skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.

The annual base salary range for this position is $96,000 to $132,000.