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: Contact: 8802762365