Product Safety Engineer

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

Overall Description：

The Equipment Compliance Engineer provides support across the company for product safety related issues, coordinates the company’s product safety compliance product programs and works through a global network of regional ECC personnel to help assure compliance at other sites

Major Accountabilities：

Primary Responsibilities

• Provides product safety /regulatory guidance and inputs from APAC countries to NPI team of capital equipment to ensure compliance of products to APAC region before market release.
• Support APAC countries registrations by obtaining and compiling relative test protocol/reports needed by MoHs, throughout collaboration with BURA and design teams, to gain GRP efficiency for early access to APA markets.
• Support local product type tests per local regulatory requirements as SME, especially trouble shooting, etc. as SME.
• Support audits to manufacturing sites requested by APAC MoH, for capital equipment as SME.
• Evaluate ECRs for APAC market impact upon design and/or manufacturing process modifications for capital equipment
• Participate in APAC regional regulatory development seminars on capital equipment on behalf of ZB.
• Participate, as needed, in the analysis & resolution of potential field related safety issues and complaints for capital equipment.
  
  

Authority

• Represent ZB interests related to trade association discussions
• Act as Product Safety contact for regional and global regulatory compliance information
  
  

Travel Requests: 50% or above (focusing on regional support as needed for local testing – China, Korea, Japan etc; and travel on site to GBU (CAS, etc) for NPI global launch discussion and knowledge transfers as needed.

Depending on the business needs of company, the supervisor of this position can give temporary or regular assignments on top of the regular responsibilities, which is not included in above responsibilities list.

The employee should know the applicable QMS requirements of the company.

Recruitment Requirements (Specific recruitment requirements can be adjusted after approved by the hiring manager for different recruitment cases)：

Key/Critical Competencies

Effective written and verbal communications skills.

Ability to work independently & proven proficiency in project management & problem-solving.

Working knowledge of MS Office tools (Word, Powerpoint, etc.) with demonstrated proficiencies in MS Office (Word, Excel, Powerpoint, Project etc).

Education and Experience

BS or advanced degree in electrical engineering, having Computer Science / Software background is plus

Demonstrated experience in managing medical equipment product safety compliance.

Experience in the design and/or testing of equipment, electromagnetic compatibility compliance

Knowledge of applicable IEC/ISO standards, and statistical applications

Demonstrated experience interacting with regulatory agencies.

Fluent in English in both written and speaking

EOE/M/F/Vet/Disability

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