Instrument Design QA Lead (Medical Devices)

Location: Stockholm, Sweden — hybrid

Company

hirify.global develops proprietary technology and direct clinical care solutions for data-driven preventative healthcare.

What you will do

• Own QA and compliance for a medical device product family covering hardware and firmware.
• Lead design controls, risk management, verification and validation strategy, design reviews, and traceability across the product lifecycle.
• Manage medical device changes, ensuring assessment, documentation, review, and approval.
• Coordinate design transfer with manufacturing QA and production teams.
• Prepare Design History Files and EU MDR technical documentation for regulatory submissions.
• Support audits, post-market surveillance, corrective and preventive actions, and continuous improvement using eQMS, automation, and AI-assisted documentation.

Requirements

• BSc or MSc in engineering, biomedical engineering, systems engineering, physics, or an equivalent technical discipline.
• At least 5 years of medical device industry experience focused on hardware, firmware, or electrical equipment.
• Hands-on expertise with design controls and risk management, including EU MDR, ISO 13485, ISO 14971, FDA 21 CFR Part 820, and FDA 21 CFR Part 11.
• Working knowledge of IEC 60601-1, IEC 62471, IEC 62304, IEC 62366, and ISO 10993.
• Systems engineering mindset with the ability to connect hardware, firmware, and system integration across a product family.
• Fluent English, strong project management, cross-functional coordination, and the ability to make decisions in an evolving environment.

Nice to have

• Swedish language skills.
• Experience with Notified Body interactions, regulatory submissions, and internal or external audits.
• Background in high-growth technology companies or startups.
• Knowledge of firmware development and embedded systems.
• Participation in medical device industry organisations or standards committees.

Culture & Benefits

• Work in a small, high-trust Quality & Regulatory team.
• Collaborate with hardware and firmware engineering, operations, and regulatory teams across an expanding product portfolio.
• Use modern digital tooling, eQMS, automated testing frameworks, and AI-assisted documentation.
• Contribute to preventative healthcare technology designed to make personalised health insights more accessible.