12 часов назад
Staff NPI Quality Engineer (Consumer Technology)
117 400 - 161 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Staff NPI Quality Engineer (Consumer Technology) (Advanced Metal Additive Manufacturing): Leading quality strategies and process validation for complex additive manufacturing products from development through scalable production with an accent on NPI readiness, SPC, risk management, and metallurgical testing. Focus on designing IQ/OQ/PQ validation, establishing process monitoring frameworks, evaluating material performance, and ensuring compliance with AS9100, ISO 9001, and ISO 13485.
Location: Devens, Massachusetts, United States; onsite
Annual base salary: $117,400–$161,500, plus equity and benefits.
Company
develops and operates industrially scalable laser metal additive manufacturing and precision machining capabilities for aerospace, defense, medical, and other essential industries.
What you will do
- Lead quality strategies, objectives, risk-based plans, deliverables, and readiness criteria for major NPI programs through production ramp.
- Define and lead IQ/OQ/PQ process validation, process characterization, capability studies, and validation plans for additive manufacturing and downstream processes.
- Monitor product and process performance, identify trends, and drive continuous improvement in quality and operational efficiency.
- Lead supplier quality activities, qualification audits, material quality reviews, and participation in the Material Review Board.
- Develop risk-management controls including FMEAs, control plans, process risk assessments, and mitigation plans.
- Establish mechanical and metallurgical testing requirements and scalable SPC and process-monitoring frameworks.
Requirements
- Bachelor’s degree in engineering, mechanical engineering, materials science, quality, or a related field, or equivalent hands-on experience.
- 6+ years of quality engineering experience, ideally in advanced or additive manufacturing.
- Experience leading complex cross-functional NPI programs or quality initiatives from development through production launch.
- Expertise in IQ/OQ/PQ, SPC, process capability, FMEA, 8D/root-cause analysis, CAPA, GD&T, and statistical problem solving.
- Knowledge of GMP, FDA QSR, ISO 13485, AS9100, and ISO 9001 quality and regulatory requirements.
- Proficiency in metrology and mechanical or metallurgical testing, with strong supplier and customer communication skills.
Nice to have
- Direct experience with metal additive manufacturing, especially Laser Powder Bed Fusion.
- Experience with titanium alloys such as Ti-6Al-4V or high-temperature alloys.
- Experience leading NPI quality for highly complex or regulated products.
- Lean, Six Sigma, or similar continuous-improvement certification.
Culture & Benefits
- Inclusive environment centered on quality, curiosity, accountability, ownership, and continuous learning.
- Medical, dental, vision, and life insurance.
- Generous paid time off.
- 401(k) plan with company match.
- Competitive equity package.
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