Fresenius Medical Care

Operates dialysis facilities and renal care

Technical Leader - Regulatory Verification

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours

Full-timeSuzhou, Jiangsu, ChinaNo salary listedHybrid

About the Job

Requirements

A BS or MS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field is required.
At least 8 years of experience in medical research and development is required; hemodialysis experience is preferred.
At least 5 years of experience in EMC testing is required; medical-device experience is preferred.
At least 5 years of experience in RF performance testing is required, preferably across 2.4 GHz and 5 GHz frequencies.
Familiarity with quality management system standards such as ISO 9001 and ISO 13485 is required.
Familiarity with IEC, GB, and YY standards, including IEC 60601-1, GB 9706.1, YY0505, IEC 61000, CISPR 11, IEC 60601-1-2, EN 300 328, and EN 301 893 is required.
Proficiency with basic test instruments, including multimeters, oscilloscopes, signal sources, spectrum analyzers, and network analyzers, is required.
Strong verbal and written English communication skills are required.
Excellent general computer and office-application skills, including Microsoft Word, Excel, and PowerPoint, are required.
Familiarity with the medical-device industry is required.
Willingness to travel when business requires it is required.

Responsibilities

Support China registration for active medical devices, primarily by handling type-testing tasks.
Coordinate between national laboratories and global experts, collecting test methods and reports to meet China NMPA type-test requirements.
Work with China regulatory affairs and global experts to prepare product technical requirement, clinical evaluation, innovation, and other submission reports.
Serve as a technical expert on global and China standards, participating in China standards and NMPA guidance drafting and discussions to protect the company's product and market.
Organize and execute verification of medical products, accessories, and modules.
Create verification documents in accordance with internal and external requirements and ensure they are audit-proof.
Coordinate verification measures required during the design-change process.
Design test methods; prepare samples; operate, debug, and simulate tests according to project needs, particularly standard-related testing.
Conduct medical-device EMC testing.
Conduct wireless-module RF compliance testing with a third party.
Create and approve submission documentation and maintain its quality compliance.
Provide technical support for RF and EMC test-system development and for team, method, and laboratory operations.
Coach internal R&D employees by providing technical introductions and training on products, including hemodialysis products.

Desired Qualifications

Experience in hemodialysis is preferred.
EMC testing experience in medical devices is preferred.
RF performance testing experience in the 2.4 GHz and 5 GHz frequency ranges is preferred.
EMC debugging experience is a plus.
Experience with ISO 17025 is a plus.
Knowledge of hemodialysis machines is preferred.

Job Responsibilities 1) Main tasks: • Support China registration for active medical devices, mainly focus on the type testing related tasks • Be the bridge of national lab and global experts, collect the test methods or reports to fulfill the type test requirement of China NMPA; • Work with China RA and global experts, prepare the dossiers like PTR (Product technical requirement), CER (Clinical evaluation report), innovation reports, etc. • As the technical expert of Global and China standards, participate in China standards and NMPA guidance drafting and discussion, protect the product and market of FMC. • Organization and execution of product verification of medical products, accessories and modules. • Creation of associated verification documents acc. to internal and external requirements, and ensure such documentation is audit-proof • Coordination of necessary verification measures in the design change process • Be a professional at test method design, samples preparing, operating, debugging & simulating according to the project needs, especially for standard related testing • Responsible to medical device EMC test • Responsible to conduct wireless module RF compliance test with 3d party 2) Secondary tasks: Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position. 3) Miscellaneous tasks: • Internal and external requirements (such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-16 etc.) • Familiar with basic EMC and wireless knowledge, preferably with relevant EMC and RF test experience • Familiar with EMC and wireless related standards (Such as IEC61000, CISPR11, EN300 328, EN301 893 etc.) • Strong technical support to RF and EMC test system building • Creation and approve submission documentation and keep them quality compliance. • Strong technical support to the Team, Method and Lab Running • Be a Coach for R&D internal employees for product (HD etc.) technical Introduction & Training. Qualifications, experience, know-how and skills critical for success* 1) Required training and education: BS or MS in EE/ME/BM Engineering or related filed 2) Required professional experience (in years): • Minimum 8 years in Medical R&D related area (Prefer HD area) • Minimum 5 years in EMC test area (Prefer medical device) • Minimum 5 ears in RF performance test area (Prefer2.4GHz and 5GHz frequency scope) 3) Important personal qualities: • Ownership & Responsibility • Hard working, focusing on Quality & Details. • Team player, good communicator 4) Other specialized knowledge: a) Technical knowledge • Familiar with QMS related standard (ISO 9001, ISO 13485 etc.) • Familiar with IEC, GB and YY standards, like IEC60601-1, GB 9706.1 and YY0505, IEC61000, CISPR11, IEC60601-1-2, EN300 328, EN301 893, etc. • Proficient in using basic test instruments (such as multimeter, oscilloscope, signal source, spectrum analyser, network analyser, etc.) • EMC debug experience is a plus • ISO 17025 experience is a plus b) Languages • Strong English verbal and written communication skills c) IT skills • Have excellent skills with general computer use and office applications such as Microsoft Word, Excel, and Power point. d) Product knowledge • Familiar with medical device industry and knowledge of HD dialysis machine is preferred 5) Special personal requirements: • Willingness to travel if business required and • Be comfortable working in a global organization • Be comfortable working under pressure

About the Company

Fresenius Medical Care

Operates dialysis facilities and renal care

Fresenius Medical Care North America provides renal care through a network of dialysis facilities and outpatient cardiac and vascular labs that deliver coordinated treatment for chronically ill patients. It also offers specialty pharmacy and laboratory services and manufactures and distributes dialysis equipment, disposables, and renal medicines. The company stands out by being the world’s largest fully integrated renal care provider with an extensive network that covers care delivery, drug and lab services, and product supply. Its goal is to ensure access to comprehensive, high-quality care for people with kidney and other chronic conditions across North America.

Company size: 11-50
Company stage: Late Stage VC
Total funding: $40.2M
Headquarters: Waltham, MA
Founded: 1996

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