Manufacturing Lead – Medical Devices
Want to have a direct impact on patient's health and life and cut down healthcare costs? Then join our growing team, where we are pioneering healthcare solutions to combat one of the most critical challenges faced by hospitals today using AI and deep-tech technology.
As our Manufacturing Lead, you'll help stand up medical-device production here in Iceland — from pilot builds to volume. You'll design the assembly processes, validate them, qualify the vendors who supply and build our hardware, and make sure everything we ship is manufacturable, repeatable, and compliant.
This is a hands-on, build-it-from-the-ground-up role at an early-stage company: you'll own how our device gets made, working shoulder-to-shoulder with our design engineers, our quality and regulatory people, and our external manufacturing partners.
- Applicants must be willing to use the numerous AI tools we use in development.
- Positive attitude
- Salary based strongly on competences.
- Good stock options plans.
- All applications are confidential.
Projects and Responsibilities:
Set Up Manufacturing in Iceland: Establish our in-house assembly and production capability — process flow, workstations, fixtures, tooling, and final-assembly procedures. Take the device from prototype and pilot builds through to repeatable, scalable production.
Process Validation and Design Transfer: Lead process validation (IQ/OQ/PQ) and support design transfer from engineering to production — building out the Device Master Record, manufacturing work instructions, and acceptance criteria so production is controlled and audit-ready.
Vendor and Supplier Management: Source, qualify, onboard, and manage our contract manufacturers and component suppliers (PCBA, mechanical, sensors, cartridge, and more).
Own quality agreements, supplier audits, incoming inspection, and second-sourcing strategy to keep the supply chain robust.
Quality and Compliance: Ensure production runs under our quality system and design controls (ISO 13485, 21 CFR 820 / QMSR, MDR/FDA expectations), with the traceability, nonconformance handling, and CAPA support a regulated medical device demands.
Design for Manufacturability and Test: Feed manufacturability and cost insight back into the product and engineering team early, and set up production test, inspection, and first-article inspection (FAI) to safeguard functionality, reliability, and safety.
Education and Competency:
Bachelor's or Master's degree in Mechanical, Industrial, Manufacturing, or Production Engineering, or a related field. Experience has higher leverage than education! We'll review all applications.
Manufacturing Engineering Expertise: Strong, demonstrable experience in manufacturing or production engineering — assembly process design, tooling and fixtures, and taking products from low to higher volume. Experience in medical devices or another regulated industry strongly preferred.
Process Validation: Hands-on experience with process validation (IQ/OQ/PQ) and production under a quality management system.
Vendor and Supply Chain: A proven track record of qualifying and managing suppliers and contract manufacturers — including quality agreements, supplier audits, and sourcing decisions.
Quality Systems: Familiarity with ISO 13485 and/or 21 CFR 820 (QMSR), design controls, DMR, and traceability.
Hands-On and Scrappy: Comfortable building things that don't exist yet, making decisions with incomplete information, and getting into the detail on the production floor. Excellent communication and teamwork skills, with a track record of working effectively across interdisciplinary teams and with external partners.
Bonus Qualifications: Experience setting up a production line or facility from scratch, or scaling a pilot to volume. Experience taking a medical device through launch (MDR/FDA). Lean / Six Sigma. Experience with electromechanical, IoT, or connected devices. Familiarity with cross-border supply chains and logistics into Iceland.
As part of our team, you'll enjoy a range of perks designed to support your professional growth and personal well-being. After all, we aim to save patients' lives!
We offer lunch and you'll also get access to the best available AI tools and technologies that will empower you to bring your innovative ideas to life.
We understand the importance of work-life balance and offer flexible working hours. We´re a family first workplace.
We offer competitive salaries based on competences and we have an impressive stock option plan for employees.
Enska