Senior Engineer, Design Assurance

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

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Masimo, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others.

Learn about the Danaher Business System which makes everything possible.

The Senior Engineer, Design Assurance is responsible for providing critical quality engineering support throughout the product lifecycle, ensuring medical device designs remain safe, effective, compliant, and aligned with user needs and business objectives. This role partners cross-functionally with engineering, regulatory, clinical, and manufacturing teams to evaluate design changes, manage product risks, maintain design integrity, and ensure continued compliance with applicable regulatory and quality system requirements. The ideal candidate possesses a strong foundation in design controls, risk management, validation principles, and post-market quality practices, and thrives in a highly collaborative environment focused on continuous product improvement and patient safety.

This position reports to the Associate Manager, Quality and is part of the Quality Assurance team located in Bengaluru, India and will be an on-site role.

In this role, you will have the opportunity to:

• Manage and maintain the Design History File (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.

The essential requirements of the job include** :**

• 3+ years of experience in Quality Engineering within the medical device industry, specifically 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.

It would be a plus if you also possess previous experience in:

• Six Sigma Green Belt Certification;
• Certified Quality Engineer (CQE);

Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Masimo we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home.

Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Masimo can provide.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.