Freelance R&D Engineer - Medical Devices

Location: Uppsala, Sweden
Contract: 12 months (freelance / independent consultant)
Start Date: ASAP
On‑Site: Mandatory - 100% on‑site, no hybrid/remote option

About the Opportunity

We are looking for a highly experienced MedTech R&D Engineer to support a cutting‑edge medical device development team based in Uppsala. This is a hands‑on, lab‑ and engineering‑focused role within a regulated medical device environment.

The assignment is ideal for a consultant with deep knowledge of medical device lifecycle management, design controls, and who is comfortable working on-site alongside cross‑functional teams including Quality, Regulatory Affairs, Systems Engineering, Manufacturing, and Clinical stakeholders.

Key Responsibilities

Medical Device R&D & Engineering

• Design, develop, and refine components, subsystems, or full medical devices (e.g., diagnostic systems, electromechanical instruments, embedded hardware, sensors, or disposable components).
• Translate clinical and user needs into engineering requirements and detailed design specifications.
• Work hands‑on with prototypes, including assembly, debugging, testing, and iteration.

Verification, Validation, and Compliance

• Plan and execute design verification and validation (V&V) activities compliant with ISO 13485, ISO 14971, IEC 60601 and/or IEC 62304 (depending on device classification).
• Develop test protocols, perform testing in the lab, analyse results, and generate documentation for audits.
• Participate in risk management, contributing to hazard analyses, FMEAs, and mitigations.

Design Controls & Documentation

• Create and maintain design control documentation including DHF inputs, requirements traceability, technical reports, test summaries, risk files, and change records.
• Ensure all engineering work meets EU Medical Device Regulation (MDR) requirements.

Cross‑Functional Collaboration

• Collaborate closely with Quality Assurance, Regulatory Affairs, Clinical, Manufacturing Engineering, and Human Factors teams.
• Support transfer of new designs into manufacturing (design for manufacturability, process validation support).
• Provide technical expertise during troubleshooting, design changes, and non‑conformity investigations.

Must‑Have Requirements

• Minimum 5 years' hands‑on experience in the medical device industry (Class I, II, or III devices).
• Deep understanding of MedTech regulatory frameworks (ISO 13485, ISO 14971, EU MDR).
• Proven experience with design verification & validation, test method development, and documentation.
• Strong technical background in mechanical, electronics, embedded systems, biomedical or mechatronics engineering within a medical device context.
• Ability to work full‑time on-site in Uppsala for the full duration of the contract.
• Excellent communication skills and comfort working cross‑functionally in a regulated environment.

Nice to Have

• Experience with EMC testing, PCB design or redesign, sensor technology, or electromechanical integration.
• Familiarity with usability engineering (IEC 62366) or human factors workflows.
• Background working in R&D teams for diagnostic instruments, infusion/monitoring systems, imaging equipment, or laboratory MedTech systems.