Remote R&D Engineer - Medical Devices & Regulatory Compliance

Pharmavise Corporation; Poland; Remote; PLN 120,000 - 180,000; Full time

Job summary

Pharmavise Corporation is seeking a talented and self-driven R&D Engineer to support the design, development, and optimization of innovative medical devices and life sciences systems. This remote role requires balancing technical expertise with regulatory discipline to transform clinical and user requirements into safe, compliant product designs.

You'll lead V&V, contribute to risk analyses, and collaborate with Quality, Regulatory, Manufacturing, and Clinical teams to ensure FDA/ISO compliance

Qualifications

• Bachelor’s degree in a technical field (Mechanical, Biomedical, Electrical) with hands-on medical device experience.
• Experience with design controls, risk management, and validation in medical device development.
• Proficiency with CAD tools (SolidWorks/Creo) and good documentation practices.
• Working knowledge of FDA Design Control (21 CFR 820), ISO 13485, ISO 14971.
• Ability to perform V&V testing, data analysis, and root-cause investigations.
• Strong technical writing and cross-functional collaboration skills.
• Exposure to regulatory compliance and product development lifecycle.

Responsibilities

• Lead end-to-end product development from concept to design transfer.
• Develop 3D models and drawings to support device design.
• Conduct design verification and validation testing and generate reports.
• Collaborate with Quality, Regulatory, Manufacturing, and Clinical teams to ensure compliance.
• Participate in risk analyses and mitigation throughout the lifecycle.
• Support Design for Manufacturability and process validation readiness.
• Prepare and maintain DHF documentation and regulatory filings.
• Drive continuous improvement using Lean Six Sigma principles.

Skills

CAD proficiency

Regulatory knowledge

V&V testing

Cross-functional collaboration

Technical writing

Data analysis

Education

Bachelor's degree in Mechanical/Biomedical/Electrical Eng

Tools

SolidWorks

Creo

Job description

Pharmavise Corporation is seeking a talented and self-driven R&D Engineer to support the design, development, and optimization of innovative medical devices and life sciences systems. This remote role requires balancing technical expertise with regulatory discipline to transform clinical and user requirements into safe, compliant product designs.

You'll lead V&V, contribute to risk analyses, and collaborate with Quality, Regulatory, Manufacturing, and Clinical teams to ensure FDA/ISO compliance