Senior Design Assurance Engineer – Remote-Eligible

Danaher Corporation; United States; Remote; USD 16.000 - 22.000; Vollzeit

Zusammenfassung

Masimo, a Danaher operating company, seeks a Senior Engineer, Design Assurance in Bengaluru, India. You will provide design controls, risk management, and post-market quality practices across the product lifecycle, collaborating with engineering, regulatory, clinical, and manufacturing teams to ensure safety, effectiveness, and regulatory compliance.

The role requires 3+ years in medical device QA, knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and experience with DHF, DFMEA, V&V, and

Qualifikationen

• 3+ years of experience in Quality Engineering within the medical device industry, supporting Design Quality.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.
• Strong ability to read and interpret complex engineering drawings, including a solid understanding of Geometric Dimensioning and Tolerancing (GD&T).
• Proven experience generating and maintaining DHF documentation, risk management documents (DFMEA/UFMEA), and PFMEAs.
• Experience reviewing V&V protocols and Test Method Validations (TMV / Gage R&R).
• Experience investigating NCRs and performing root cause analysis.
• Proficiency with Microsoft Office applications.
• Strong communication, documentation, problem solving and leadership/management skills.
• Ability to occasionally travel internationally.
• Bachelor’s Degree (B.E.) in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.

Aufgaben

• Manage and maintain the DHF.
• Perform routine DHF audits to ensure continuous compliance.
• Review and approve design requirements (PDR/Requirements Matrix) and design changes (Change Orders) to ensure appropriate validation and verification (V&V) requirements are met.
• Collaborate cross-functionally to create and maintain risk management files and documents.
• Ensure all risk assessments are updated concurrently with design changes.
• Review and approve Test Method Validation (TMV) protocols and reports (e.g., Gage R&R) to ensure measurement systems are reliable prior to V&V execution.
• Monitor post-market feedback for early-stage products to ensure stable field performance, generating PMS Reports and Field Feedback Reviews.

Kenntnisse

Quality Engineering

GxP Knowledge

FDA 21 CFR 820

ISO 13485

ISO 14971

GD&T

DHF & DFMEA

V&V

NCR Investigation

MS Office

Travel

Communication skills

Ausbildung

BE in Biomedical/Mechanical/Electrical Eng

Jobbeschreibung

Masimo, a Danaher operating company, seeks a Senior Engineer, Design Assurance in Bengaluru, India. You will provide design controls, risk management, and post-market quality practices across the product lifecycle, collaborating with engineering, regulatory, clinical, and manufacturing teams to ensure safety, effectiveness, and regulatory compliance.

The role requires 3+ years in medical device QA, knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and experience with DHF, DFMEA, V&V, and