SW Product Quality Engineer

Job Title

Job Description

Job title:
Quality In Design: SW Product Quality Engineer MR (CG50)

As an SW Product Quality Engineer within the MR Business Unit you are accountable for enabling Quality in Design across MR software products throughout the full lifecycle. You provide hands-on software quality engineering support to development teams ensuring design controls risk management and quality planning are effectively applied to deliver safe reliable and compliant software products that meet regulatory and business expectations.

Your Role

• Provide end-to-end software design quality support across concept development verification release and lifecycle maintenance.
• Define and maintain Software Quality Plans aligned with MR QMS PSQ strategy and applicable regulatory standards.
• Validate key software design inputs including usability reliability performance safety security privacy serviceability sustainability and cost.
• Support execution of software risk management activities including software FMEAs and hazard analyses ensuring risks are identified mitigated and appropriately controlled.
• Support achievement of defined software quality and reliability targets at project milestones.
• Lead and support software quality issue investigation and problem solving during development and post-market phases.
• Analyze development verification and post-market data to identify trends and provide feedback to R&D Manufacturing Suppliers and Service.
• Support Periodic Quality Reviews (PQRs) through structured analysis data analytics and appropriate use of intelligent analytics (IA).
• Act as the designated quality partner / point of contact for assigned project teams.
• Contribute to the effective application of Agile development practices within a regulated medical software environment.
• Provide global cross-site support to MR software teams in Bangalore Best Pune and Suzhou.

Key Responsibilities

• Support execution of software design control activities in accordance with MR QMS and applicable standards.
• Participate in design reviews to assess software robustness risk controls and readiness for next-phase progression.
• Support translation of software risk controls into clear verifiable and traceable requirements.
• Collaborate with Verification & Validation teams to ensure adequate software verification validation and usability testing.
• Review and contribute to Design History File (DHF) and Device Master Record (DMR) documentation to ensure accuracy completeness and audit readiness.
• Support regulatory submissions audits inspections and CAPA activities with objective evidence and quality expertise.
• Contribute to continuous improvement of software quality reliability and QMS effectiveness within MR.

Youre the Right Fit If

• Education: Bachelors degree in Engineering with 812 years of relevant experience or Masters degree with 610 years of experience.
• Experience: Hands-on experience in software quality reliability engineering or software development within a regulated industry (medical devices healthcare aerospace or similar).
• Standards & Regulations: Working knowledge of 21 CFR 820 ISO 13485 IEC 62304 IEC 62366 and ISO 14971.
• Regulatory Application: Experience applying design controls and risk management practices to support audits inspections and regulatory submissions.

Soft Skills & Behavioral Expectations

• Strong written and verbal communication skills with the ability to clearly articulate technical and quality topics to diverse stakeholders.
• Ability to create clear concise and audit-ready quality records suitable for inclusion in the DHF.
• Sound judgment and structured risk-based thinking to support quality decisions.
• Strong collaboration and stakeholder management skills with the ability to influence without direct authority.
• Ability to operate effectively in a complex multi-project and fast-paced R&D environment.

How we work together
We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre interested in this role and have many but not all of the experiences needed we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.