Product Safety Engineer (Karnataka)

Product Safety Engineer (Karnataka)

01 Aug
|
Zimmer Biomet
|
Karnataka

01 Aug

Zimmer Biomet

Karnataka

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 setting 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

📌 Product Safety Engineer (Karnataka)
🏢 Zimmer Biomet
📍 Karnataka

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