Self type testing Lab Manager
Philips is a global health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
In this role, you have the opportunity to make life better:
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
In this role, you have the opportunity to become part of and grow a team of subject matter experts with passion for bringing the highest quality of electrical (sub)systems and solutions to the Chinese market in compliance with national regulations and standards.
Although your primary responsibilities evolve around the growth and optimization of a modern local EMC lab in Suzhou, you’ll be working in close contact with an international team of experts to harmonize and optimize local procedures to enable faster time to market of innovative Interventional Guided Therapy systems and solutions.
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.
You are responsible for:
• Lead the self-type testing lab in general, for operation efficiency, finance balance, lab infrastructure built 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 self-type testing lab receives and maintains CNAS accreditation and CSA certificate against the latest ISO 17025, YY and GB-standards.
This involves participation in (international) proficiency testing and reporting.
• Support projects in creating compliant type testing plan, EMC 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.
Grow and 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.
You are a part of Quality team in Suzhou.
To succeed in this role, you should have the following skills and experience Minimum Qualifications:
• Bachelor’s degree or above in Electronics, Electrical or Biomedical Engineering, major in medical or engineering
• More than 10+ years technical experience and 3~5 years leadership 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 (EMC) test laboratories.
• Familiarity with Active diagnostic image product (like Xray, CT, MR, Ultrasonic) , angiographic X-ray product and EMC product related standards such as: IEC 60601-1 (GB 9706), IEC 60601-1-2 (YY 05050), 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)
• 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
In return, we offer you:
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.