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Instrument Design
2 weeks ago
Posted exclusively on behalf of our Medtech client
Location:
Stockholm, Sweden, Hybrid working
We are seeking an exceptional Instrument Design Quality Lead to drive quality assurance strategy and leadership across instrument development. This is a key role within a cutting-edge medtech organization, offering the opportunity to shape quality systems, influence cross-functional engineering teams, and lead with impact during a period of rapid growth and scale.
In this position, you'll be the primary owner of design control, risk management, regulatory compliance, and the development of audit-ready technical documentation and DHFs. You will partner closely with instrument engineering leaders to ensure products are developed safely, efficiently, and in full compliance with global standards.
This is a pivotal moment to join core frameworks are in place, and now the focus shifts to scaling, system-building, and automation. You'll begin with a small team of direct reports, with the mandate to grow and shape your own QA Hardware Design team.
But this role goes beyond compliance. We're looking for a strategic thinker who can balance business needs with quality expectations, foster a culture of operational excellence, and help accelerate innovation in a tech-forward, fast-scaling environment.
What You'll Do
- Define and drive the QA strategy for hardware and instrument development.
- Lead, mentor, and grow your QA team - starting with 1-2 direct reports and expanding further.
- Build and maintain audit-ready DHFs, risk files, and design documentation.
- Own design control and risk management strategies, ensuring compliance with MDR and FDA.
- Implement tools, automation, and digital processes to streamline documentation and design control.
- Establish data-driven QA systems, setting up KPIs to monitor CAPA, complaints, and QMS performance.
- Partner with hardware/firmware engineering, suppliers, and labs to drive quality outcomes across development.
- Prepare the organization for audits and inspections.
- Act as a coach and influencer across R&D and management - embedding quality thinking into daily decision-making.
Who You Are
- 8+ years in Design QA roles in the medical device hardware/instrument industry.
- Proven leadership and people management skills, with experience hiring and building teams.
- Expertise in design controls, risk management, and DHF ownership.
- Strong knowledge of MDR, FDA, and standards such as ISO 13485, ISO 14971, IEC 60601, IEC 62366, ISO 10993.
- Comfortable in scale-up environments — proactive, adaptable, and fast-moving.
- Tech-savvy, ideally with coding or DevOps mindset — able to leverage tools and automation for QA processes.
- Strong judgment, communication, and ability to influence and collaborate across engineering and leadership teams.
- BSc/MSc in Engineering, Physics, Biomedical Engineering, or related field.
- Excellent English communication; Swedish a plus.
Nice to Have
- Experience with active (hardware) medical devices.
- Exposure to AI-enabled or software-driven devices.
- Experience scaling QA operations in fast-growing MedTech companies.
- Supplier quality management and external lab coordination experience.
Why Join?
- Lead the transformation of QA in instrument and hardware development.
- Be empowered to build your own team and set strategy.
- Work with an open, collaborative manager who values independence and proactive problem-solving.
- Shape systems and processes in a fast-paced, high-impact MedTech environment.
Apply on LinkedIn
Ready to make your mark? Don't hesitate - apply today as interviews can be scheduled within a week.
