Quality Engineer (Hardware & Production) Porto

SWORD Health; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is on a mission to revolutionize healthcare through AI-driven solutions. As a Quality Engineer, you will ensure the highest standards in hardware components for medical devices, collaborating with diverse teams to enhance patient outcomes. This role offers a unique opportunity to make a significant impact in a rapidly growing company that values innovation and excellence. Join a passionate team dedicated to creating a pain-free world, where your contributions will directly influence the quality of life for millions. Embrace the chance to grow in a dynamic environment that fosters creativity and commitment.

Benefits

Gesundheits-, Zahn- und Augenversicherung

Essenszulage

Aktienoptionen

Remote-Arbeitszulage

Flexible Arbeitszeiten

Discretionary Urlaub

Snacks und Getränke

Englischkurse

Qualifications

• 2–4 Jahre Erfahrung in Qualitätssicherung oder Engineering, vorzugsweise im Bereich medizinische Geräte.
• Kenntnisse in ISO 13485, FDA 21 CFR 820, und Risikomanagement.

Responsibilities

• Definieren und Aufrechterhalten von QA-Strategien über den Produktlebenszyklus.
• Leiten von Untersuchungen zu Nichtkonformitäten mit Tools wie 5 Whys und FMEA.

Skills

Qualitätssicherung

Regulatorische Compliance

Produktentwicklung

Risikomanagement

Dokumentation

Statistische Qualitätswerkzeuge

Six Sigma

Education

Bachelor in Naturwissenschaften oder Ingenieurwesen

Tools

FMEA

Fishbone-Diagramme

Job description

Sword Health is on a mission to free two billion people from pain.

With 67% of members achieving a pain-free life and a 70% reduction in surgery intent, at Sword, we are using AI Care to change lives, and save millions for our 25,000+ enterprise clients across three continents. Today, we hold the majority of industry patents, win 70% of competitive evaluations, and have raised more than $300 million from top venture firms like Founders Fund, Sapphire Ventures, General Catalyst, and Khosla Ventures.

Recognized as a Forbes Best Startup Employer in 2025, this award highlights our focus on being a destination for the best and brightest talent. Not only have we experienced unprecedented growth since our market debut in 2020, but we’ve also created a remarkable mission and value-driven environment that is loved by our growing team. With a recent valuation of $3 billion, we are in a phase of hyper growth and expansion, and we’re looking for individuals with passion, commitment, and energy to help us scale our global impact.

Joining Sword means committing to a set of core values, chief amongst them to “do it for the patients” every day, and to always “deliver more than expected” on behalf of our members and clients.

This is an opportunity for you to make a significant difference on a massive scale as you work alongside 900+ (and growing!) talented colleagues, spanning three continents. Your charge? To help us build a pain-free world, powered by AI, enhanced by people — accessible to all.

Introduction :

Sword Health is a healthcare company that provides AI care programs to address physical pain. We are committed to delivering high-quality medical devices (software and hardware) that improve patient outcomes and safety. We are seeking a talented and detail-oriented Quality Engineer (Hardware & Production). Reporting to the Expert Quality Engineer, you will play a crucial role in ensuring the quality and regulatory compliance of hardware components of medical devices and maintaining quality throughout production lines. Collaboration with cross-functional teams including research, hardware development, supply chain, and regulatory affairs is essential. The ideal candidate resides in the Porto area.

Key Responsibilities:

1. Hardware Quality Assurance: Define and maintain QA strategies across the product lifecycle, support design transfer activities, ensure compliance with ISO 13485, FDA 21 CFR 820, IEC 60601, and conduct audits.
2. Process Improvement: Participate in validation lifecycle improvements, develop process KPIs, leverage data for continuous improvement, and contribute to change control assessments.
3. Regulatory Compliance: Translate regulatory requirements into practical quality controls and ensure validation activities meet expectations.
4. Supplier Management: Qualify and monitor critical suppliers, support audits, and implement quality agreements.
5. Root Cause Analysis: Lead investigations into non-conformities, utilizing tools like 5 Whys, Fishbone Diagrams, and FMEA.
6. Risk Management: Collaborate on FMEAs, ensure risk control measures are implemented and residual risks are documented.
7. Documentation and Reporting: Maintain validation documentation, track quality metrics, and report KPIs to leadership.

Hard Skills and Expertise:

• Bachelor's degree in Science, Engineering, or related field.
• 2–4 years of experience in Quality Assurance or Engineering, preferably in medical device hardware.
• Understanding of quality systems, design controls, CAPAs, and non-conformities.
• Experience with product development, design transfer, and relevant regulations (ISO 13485, 21 CFR 820, ISO 14971, ISO 60601).
• Knowledge of validation activities, risk analysis tools, and statistical quality tools.
• Structured problem-solving skills, familiarity with Six Sigma or Lean is a plus.
• Fluent in English.

Soft Skills and Attributes :

• Mission-first mindset, owner mentality, and delivering more than expected.
• Fast learner, adaptable, and resilient under pressure.
• Resourceful, efficient, and collaborative communicator.

Portugal - Sword Benefits & Perks:

• Health, dental, and vision insurance
• Meal allowance
• Equity shares
• Remote work allowance
• Flexible hours and work from home
• Discretionary vacation
• Snacks and beverages
• English classes

Note: This position does not offer relocation assistance. Candidates must have a valid EU visa and reside in Portugal.

Sword Health is committed to non-discrimination and complies with applicable civil rights laws.