Systems Test Engineer

Philips Iberica SAU; Pune District; On-site; INR 10,00,000 - 15,00,000; Full time

Job summary

A health technology company is seeking a skilled Systems Test Engineer in Pune District, India. Responsibilities include creating and executing verification plans, testing and validating medical devices, particularly ventilators, and ensuring compliance with quality systems. Candidates should have a Bachelor's or Master's degree in a relevant engineering field and 6 to 9 years of experience in system verification. Strong communication, collaboration skills, and knowledge of FDA/ISO regulations are essential. This is an in-office position with a team-oriented culture.

Qualifications

• 6 to 9 years of experience on system verification and validation of medical devices.
• Experience on V&V of ventilator is preferred.
• Strong understanding of FDA and/or ISO/IEC regulations.

Responsibilities

• Create Verification and Validation plan.
• Testing and debug of critical sub-assemblies.
• Conduct early dry run testing of system verification test procedures.
• Perform system-level formal verification prior to production release.

Skills

System verification and validation

Test method validation

Quality management systems knowledge

Effective communication skills

Collaboration skills

Education

Bachelor’s or Master’s degree in Mechanical / Electronics / Electrical / Biomedical Engineering

Tools

MS Office

Job description

Systems Test Engineer

Job title: Systems Test Engineer

Your role:

• Create Verification and Validation plan.
• Testing and debug of critical sub-assemblies.
• Conduct early dry run testing of system verification test procedures to ensure their high accuracy as well as provide timely information on product performance to the project team.
• Perform system-level formal verification prior to production release to identify problems.
• Perform V&V activities for FDA and EUMDR remediation projects.
• Design test protocols and develop test methods.
• Reporting and documenting the test results in test reports and where appropriate, entering defects into the defect tracking system.
• Enables and/or performs functional testing through the development of robust and reusable tests.
• Work with design teams to isolate design errata, perform failure analysis, and verify design fixes.
• Support and work collaboratively with external teams to verify system performance.
• Supporting the test estimation and planning activities.
• Ensuring that all verification activities are conducted in accordance with Quality System requirements.
• Following improvements in the profession of test engineering.
• Mentor team members.
• Ability to implement process automation/innovation.
• Ability to learn new PLM/ALM tools and become productive.

You’re the right fit if:

• Bachelor’s or Master’s degree in Mechanical / Electronics / Electrical / Biomedical Engineering with a broad technical understanding and interest.
• Minimum 6 to 9 years of experience on system verification and validation of medical devices.
• Experience on V&V of ventilator will be preferred.
• Hands on experience of test method validation.
• Hands on experience of remediation projects for FDA or EUMDR.
• Understand and Comply with Philips QMS.
• You are process oriented with basic knowledge of FDA and/or ISO/IEC regulations.
• Technical documentation authoring and editing skills.
• Good written and verbal communication skills.
• Ability to work across functional groups.
• Familiarity with quality procedures and documentation.
• Proficiency with MS Office MS excel or equivalent.
• Good communication of both written and spoken English.

How we work together

We believe that we are better together than apart. This is an office-based role, which means working in-person at least 3 days per week.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't 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 you’re 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 commitment to diversity and inclusion here.