Senior Medical Device Quality Engineer hos Flow Neuroscience i Malmö
Ansvarar för kvalitet och regulatoriska ramverk genom hela produktlivscykeln, inklusive designkontroll och teknisk dokumentation. Du har teknisk erfarenhet av medicintekniska produkter samt erfarenhet av ISO 13485 och FDA-regleringar.
Titel, arbetsplatsens namn och sammanfattning skrivna av AI utifrån annonsen.
Bra att veta
Lön
Inom yrkesgruppen Civilingenjörsyrken inom elektroteknik har de som jobbar i privat sektor i Sydsverige i snitt 56 700 kr i månaden, varav 55 700 kr i grundlön. I hela landet, i privat sektor, tjänar hälften mellan 46 500 kr och 63 700 kr, och de som är 18–24 år har i snitt 37 500 kr. Det är statistik för yrket, inte vad den här arbetsgivaren betalar.
Källa: SCB, lönestrukturstatistik 2025
Anställningen
Anställningen har inget slutdatum. Den kan börja med en provanställning på högst sex månader. Vill arbetsgivaren avsluta den under provtiden ska du få besked minst två veckor i förväg; annars blir den en vanlig tillsvidareanställning när provtiden är slut. Därefter krävs sakliga skäl för att säga upp dig, och uppsägningstiden är minst en månad, längre ju längre du har varit anställd.
Ett kollektivavtal kan ge andra regler än lagen.
Texten är skriven med AI och kan innehålla fel. Kontrollera med arbetsgivaren.
Källa: Lagen om anställningsskydd (LAS)
Arbetsgivaren
Det är deras första annons inom yrkesgruppen Civilingenjörsyrken inom elektroteknik på två år.
Källa: vår sammanställning av Arbetsförmedlingens annonser
Senior Medical Device Quality & Regulatory Engineer
Senior Medical Device Quality & Regulatory Engineer
At Flow Neuroscience, we're building the future of mental health treatment — combining neuroscience, hardware, and software to deliver clinically proven, non-drug therapy at scale.
Our flagship product, the Flow FL-100, is an at-home treatment for major depressive disorder, one of the leading causes of disability worldwide. It is the first neuromodulation treatment FDA-approved as a standalone, at-home treatment for major depressive disorder.
Following regulatory approvals in Europe, UK, Australia, and the US, we're entering a new phase of growth — scaling manufacturing, strengthening our quality systems, and expanding globally.
We're now looking for a Senior Medical Device Quality Assurance & Regulatory Engineer to take a central role in maintaining and evolving our QA, QMS, and regulatory infrastructure.
The Role
You will own and drive critical parts of our quality and regulatory framework across the full product lifecycle — from design and development through manufacturing at our contract manufacturers, post-market, and supporting regulatory submissions. You will act as the technical owner for key product lifecycle and quality processes, driving cross-functional projects across R&D, manufacturing, quality and regulatory.
This is a high-impact role at the intersection of engineering, manufacturing, quality, and regulatory strategy. You will be embedded within our technical teams and work closely with Quality, Regulatory, and Supply Chain.
What You'll Do
- Lead and maintain Design Control processes (design history file, verification/validation, risk management, device change control)
- Own and maintain Technical Documentation / Technical Files / DHFs / DMRs
- Drive supplier qualification, auditing, and ongoing manufacturing quality control and improvements
- Collaborate closely with R&D on design changes and process improvements
- Support and continuously improve our ISO 13485-certified QMS
- Support regulatory submissions and updates (EU MDR, FDA)
- Ensure compliance with evolving regulations, including FDA QMSR, EU and UK MDR changes
- Support audits (Notified Body, FDA, suppliers, internal) and inspection readiness
- Work cross-functionally with product, regulatory, and operations teams
What We're Looking For
You're someone who understands both the letter of the regulations and the reality of building a product in a fast-moving company. You have a strong technical background in either medical-device software or hardware/product engineering, combined with hands-on experience in medical-device design, development and manufacturing.
Core Competencies
- Very strong technical project management skills
- Strong technical experience with active medical devices
- Strong understanding of design and development controls under ISO 13485 and FDA QMSR (21 CFR Part 820)
- Hands-on experience with supplier and manufacturing quality control
- Proven experience managing Technical Files / DHF / DMR
- Expertise in ISO 13485 QMS implementation and maintenance
- Experience with FDA regulations (QMSR) and EU MDR
- Experience with FDA inspections and/or Notified Body audits
- Bonus (Highly Valuable)
- Experience with FDA PMA devices (Class III) and PMA supplements
- Background in combination hardware/software medical devices
Quality management system automation, eQMS & AI-tools.
Experience working closely with Asia-based contract manufacturers
Experience working with neurotech.
Who You Are
- You take ownership and operate with high autonomy
- You're structured, detail-oriented, and pragmatic
- You can translate regulatory requirements into efficient processes
- You enjoy working cross-functionally with engineers and operators
- You're comfortable in a scaling environment where not everything is fully defined, and you enjoy building the processes and systems that are missing
Location
Hybrid. Skåne, Sweden, or London, UK. You will be expected to work from one of our offices a few times per week.
Avsnitt som inte handlar om jobbet är utelämnade. Hela annonsen finns hos Arbetsförmedlingen.
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