Research And Development Engineer

We’re Hiring: R&D Engineer & QA Engineer – Medical Device Design & Development

Join us in building high-impact, compliant, and innovative medical devices that truly make a difference. We are expanding our Engineering & Quality teams and looking for experienced professionals with strong expertise in regulated environments.

R&D Engineer – Medical Device Design & Development

We’re seeking a hands-on R&D professional with strong Design Control experience and exposure to commercialization.

Key Responsibilities:

✔ Specs Creation (Product Specifications, Design Inputs & Outputs)

✔ Work on NPD / NPI projects from concept to commercialization

✔ Lead Risk Management remediation & support DHR documentation

✔ Support 510k submission activities

✔ DMR documentation & PLM management

✔ Verification & Validation activities

✔ Preparation of Test Protocols & Test Reports

✔ DQC & DQA participation

✔ Aging Testing coordination

✔ Handle ECN / ECR processes

✔ Use tools like Jira, Git & statistical tools (Minitab)

✔ Collaborate with BE Medical Systems & cross-functional teams

Required Experience:

Bachelor’s/Master’s in Biomedical / Mechanical / Electrical Engineering

3+ years in Medical Device Design & Development

Strong knowledge of Design Control, ISO 13485 & FDA 21 CFR Part 820

Experience in Risk Management & Regulatory documentation

QA Engineer – Medical Device Design & Development

We’re looking for a strong QA professional to ensure compliance, audit readiness, and quality excellence across design & development.

Key Responsibilities:

✔ Review & approve Specs, Test Protocols & Test Reports

✔ Drive ECN / ECR approvals

✔ Lead DQA activities & participate in DQC reviews

✔ Ensure DHR completeness & QMS compliance (Compliance Quest)

✔ Support 510k submission documentation

✔ Oversee Verification & Validation documentation

✔ Risk Assessment & Mitigation activities

✔ Maintain audit readiness (ISO 13485 / FDA 21 CFR 820)

✔ Support Aging Testing & Product Launch activities

Required Experience:

Bachelor’s/Master’s in Engineering

3+ years in Medical Device QA

Strong knowledge of Design Control, Risk Management & Regulatory Standards

Experience with QMS systems (Compliance Quest preferred)

What We Offer:

✨ Competitive salary & benefits

Growth & leadership opportunities

Collaborative work environment

Continuous learning & mentorship

If you have strong experience in Specs Creation, ECN/ECR, NPD/NPI, 510k submission, DHR, PLM, Verification & Validation, Test Protocols & Reports, DQC/DQA, and Aging Testing, we’d love to connect.

Apply or Connect:

Email: mtewari@fiunex.com

Contact: 8802762365