Remote R&D Engineer - Medical Devices & Compliance

Pharmavise Corporation; United States; Remote; USD 110,000 - 145,000; Full time

Benefits offered by this job

Remote work

Job summary

Pharmavise Corporation seeks a remote R&D Engineer to support design, development, and optimization of innovative medical devices and life sciences systems. The role emphasizes FDA/ISO 13485/ISO 14971 awareness and collaboration with cross-functional teams to deliver safe, manufacturable, regulatory-compliant technologies.

The ideal candidate will lead end-to-end development, conduct design verification and validation, and ensure Design Control documentation aligns with 21 CFR 820 and risk

Qualifications

• Bachelor’s degree in a technical field (Mechanical/Biomedical/Electrical).
• Experience in medical device product development, including design controls and risk management.
• Proficiency with CAD tools (SolidWorks/Creo) and engineering docs.

Responsibilities

• Lead end-to-end product development lifecycle from concept to transfer.
• Perform V&V testing, analyze data, generate reports demonstrating regulatory compliance.
• Collaborate with Quality/Regulatory/Manufacturing/Clinical teams on Design Control and ISO 14971 risk management.
• Support DHF documentation and design transfer / process validations for production.
• Apply Lean Six Sigma, statistics, and continuous improvement to design quality.

Skills

CAD proficiency

V&V testing

Regulatory documentation

Cross-functional collaboration

Technical writing

Education

Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering

Tools

SolidWorks

Creo

Job description

Pharmavise Corporation seeks a remote R&D Engineer to support design, development, and optimization of innovative medical devices and life sciences systems. The role emphasizes FDA/ISO 13485/ISO 14971 awareness and collaboration with cross-functional teams to deliver safe, manufacturable, regulatory-compliant technologies.

The ideal candidate will lead end-to-end development, conduct design verification and validation, and ensure Design Control documentation aligns with 21 CFR 820 and risk