Test Engineer

Location: Suzhou

Time Type: Full time

Job Description

Job Title

Job Description

1． PURPOSE

You’ll work within a multi-disciplinary team on applying research results and technology advancements, while taking care that our systems and solutions (including components, parts, subsystems and integrations with 3rd party devices) complies with the local and international EMC standards, safety performance standards and (international) regulations.

2、PRINCIPAL ACCOUNTABILITIES

• Be responsible for the Quality testing lab in general, for operation efficiency, lab infrastructure build up, good lab management system per ISO17025, equipment management, testing capability development, and IEC/GB applicable standard up to date.

• Plan, schedule, manage, conduct and support (type approval) tests on active medical device (sub)system (e.g., type testing including EMC, Safety, Performance) for assigned projects performing NMPA submissions for initial-, change- and renewal market licenses.

• Ensure the Suzhou quality testing lab maintains CNAS accreditation and CSA certificate against the latest ISO 17025, YY and GB-standards. Support projects in creating compliant type testing plan, safety test plans, based on the products technical file and accompanying documentation.

• Perform type testing, collect data and report according to the requirements of the IEC standards and NMPA regulations.

• Work with different agencies, including NMPA, certified body like CSA, Intertek, and notified body like DEKERA, TUV SUD, BSI etc., to support the product certifications, audits and training.

• Coordinate and work with global NPI or MLD project/R&D team to complete the Approbation testing report per IEC standards, which is recognized by certified body. It serves the fundamental of general safety and performance requirement compliance evidence to enable the global regulatory submission for EU MDR, 510k, etc.

• Coordinate and work with L4L project team to transfer production of PD and IGT systems and solutions for production and maintenance in China in alignment with the product platform design and architecture requirements.

• Support the regulatory affair team in product submissions and answering (technical) supplementary questions from NMPA.

• Develop, extend and maintain test capabilities per the applicable IEC/GB standards, in terms of lab facility, equipment, and test personnel qualification. Train the local team in close alignment with the global quality and regulatory teams.

• Cooperate with Philips laboratories in other geographic regions on harmonization and optimization of the quality management system and standard operating procedures. This includes automation of repetitive tasks and activities to prevent human mistakes.

3、JOB REQUIREMENTS

• Bachelor’s engineering degree, or equivalent experience.

• More than 10+ years technical experience in medical device approbation or 3rd party testing agency for IEC 60601-1 serials standards, and NMPA witness type testing, third-party witness tests or working in medical device safety test laboratories.

• Prefer to be familiar with Active diagnostic image product (like Xray, CT, MR, Ultrasonic), angiographic X-ray product and related standards such as: IEC 60601-1 (GB 9706), IEC 60601-1-2 (YY 0505), IEC60601-1-3, IEC60601-2-43, and GB/YY standards. It is preferred to being familiar with China and international standard structures and procedures.

 • Good language skills in writing and speaking in English and Mandarin

• Excellent communication and interpersonal skill

• Natural eagerness to take ownership for problem solving and continues improvement

• Experience in new product introduction and / or life-cycle development in the (medical) industry (Quality and improvement driven) is preferred.

• Being a team player with good leadership skills (soft skills)

• Able to work in cross functional teams

• Proactive and energetic

• Hands on and accurate

• Long-term result drive

About Philips
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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 culture of impact with care here.