Essential Duties and Responsibilities

- Establish standard methods for manufacturing testing & requirements thereof
- Compile the inputs and document the requirement to Production Safety Test System Requirements (TSR)
- Responsible to maintain the Production Safety Test System Requirements.
- Own creation, Review and Disposition Documents such as manufacturing test specifications.
- Use tools such as DOORS POLARION or equivalent and excels in the management of requirements and decomposition of system level requirements to modules and their respective compliance requirements
- Use tools like AGILE for PDLM management
- Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety
- Excels in the application of principles of Reliability and Robustness in the development of products or solution
- Completes detailed, high quality technical documentation to capture and communicate manufacturing requirements
- Lead the effort in complying with IEC 60601-1 and collateral standards for manufacturing tests to stay compliant to notified bodies requirements (DQS, UL, ETL, TUV, LNE,etc.)
- Provides support during Notified Body audits & follow-ups
- Collaborate with contract manufacturers in context of manufacturing requirements and govern to sustain the validated status of manufacturing and testing




- Collaborate with manufacturing and process engineering from Baxter Manufacturing sites to sustain the compliant and validated status of manufacturing and testing of the products.

Qualification, Education and Experience

- Bachelor's Degree in Mechanical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
- 3 to 8 yrs of experience, mainly in Manufacturing & testing function of Electro-Mechanical System Design.
- Experience in Medical Device development, FDA Regulations and MDR. Experience in QFD, Pugh Matrix, CTQ, DFR, DFX
- Strong interpersonal skills with the ability to collaborate with others in a team workplace
- Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
- Excellence in Medical Devices safety (IEC 60601-1 and collaterals for medical devices like cardiology, patient monitoring and respiratory therapies), FDA Regulations or other applicable regulatory requirements.
- Excellence in Medical Device software life cycle processes (IEC 62304), EMI/ EMC requirements, REACH, ROHS and Biocompatibility.
- Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously
- Self-motivated with good interpersonal skills.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Engineer II, Design Transfer (Karnataka)
🏢 BAXTER
📍 Karnataka