Senior Engineer, Design Assurance

Radiometer; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Masimo, Bengaluru, India, seeks a Senior Engineer, Design Assurance to provide critical quality engineering across the product lifecycle in medical devices.

You will collaborate with engineering, regulatory, clinical and manufacturing teams to maintain DHF, manage risk, validate designs, and ensure compliance with FDA/ISO standards, with occasional international travel.

Qualifications

• 3+ years in Quality Engineering for medical devices.
• Experience with FDA 21 CFR Part 820, ISO 13485 & ISO 14971.
• Ability to read engineering drawings with GD&T.
• Experience maintaining DHF, DFMEA/UFMEA and PFMEA.
• Experience with V&V protocols and TMV/Gage R&R.
• NCR investigations and root cause analysis experience.
• Proficiency in MS Office.
• Willingness to travel internationally.

Responsibilities

• Manage and maintain the Design History File with regular audits.
• Review/approve design requirements and Change Orders for V&V.
• Collaborate to maintain risk management files updated with design changes.
• Review TMV protocols/reports to ensure measurement reliability.
• Monitor post-market feedback and generate PMS/Field Feedback Reviews.

Skills

Quality Engineering

Design Quality

Regulatory Compliance

Documentation

Root Cause Analysis

Communication

Education

Bachelor’s Degree in Biomedical/Mechanical/Electrical Engineering

Tools

Gage R&R

TMV Protocols

MS Office

Job description

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.

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

• Six Sigma Green Belt Certification; Certified Quality Engineer (CQE);
• Bachelor’s Degree (B.E.) in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.

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. 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. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.