Job Description

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

The role of Senior C&S Engineer is to make technical contribution in defining the applicable safety and regulatory standards for an assigned product, project or solution. The Senior C&S Engineer shall ensure compliance to safety and regulatory standards during appropriate phases of the project. He / She provides guidance to other engineers on their technical issues, engages in design reviews and help resolves problems of higher complexity. The Senior C&S engineer shall also create and maintain the CE mark and related documentations for all applicable products. ESSENTIAL DUTIES AND RESPONSIBILITIES: Works effectively with Regulatory Affairs and understand and translate regulatory requirements to safety requirements for compliance.

• Excels in providing input to the System Engineer regarding the applicable codes and safety standards for the development of medical device or solution during design input phase of the project and in the development of Essential Requirements
• Excels in providing design guidance related to Codes & Standards to the core team members during development phases of the projects.
• Excels in creating regulatory and safety tests plan detailing the applicable medical device regulations and safety standards the product must comply with.
• Excels in performing impact assessment to product safety requirements when design change is implemented in the product.
• Lead the effort in complying with IEC 60601-1 and collateral standards to obtain product approvals from external safety test labs and notified bodies (DQS, UL, ETL, TUV, LNE, etc.)
• Provide required assistance to V&V engineer in completing safety testing and creating test records related to C&S requirements.
• Excels in obtaining and maintaining 3rd party Product Certifications, Type approvals and technical files.
• Excels in the creation and maintenance of Clinical Evaluation Reports (CER).
• Provides support during Notified Body audits & follow-ups.
• Excel in the creation and maintenance of technical files to the MDD and STED to MDR for CE mark
• Excels in providing support in the creation of Declaration of Conformance for applicable products.
• Support in the creation and maintenance of Declaration of Conformity.
• Communicates and educates R&D teams on codes & standards requirements, and their implementation.
• Collaborates with QA/RA to register products in different geographical regions.
• Documents status and results accurately and succinctly, and with purpose.
• Coach and mentor the performance of junior members to perform and excel in the functions of C&S Engineer
• Generates alternatives and takes reasonable risks while solving technical problems.
• Seeks knowledge of the business, market, industry and competitive environment.
• Uses existing tools and best practices to report and track product and process metrics.
• Informs others proactively about developments or issues that affect their work, and their ability to meet commitments.
• Other duties may be assigned.

Qualifications - External
EDUCATION AND EXPERIENCE:

• Bachelor’s Degree in Engineering or local equivalent of same; generally, 5 - 7 years of experience.

QUALIFICATIONS AND SKILLS:

• Excels in translating clauses from the safety standards to technical design requirements.
• Excels in liaising and coordinating with external test houses / labs for conducting product certifications and safety test execution.
• Excels in Medical Devices safety (IEC 60601-1 and collaterals), FDA Regulations or other applicable regulatory requirements.
• Excels in Medical Device software life cycle processes (IEC 62304), EMI/ EMC requirements, Mattress Flammability, E&L, REACH, ROHS and Biocompatibility.
• Ability to generate alternative solutions to problems or processes.
• Strong interpersonal skills with the ability to work collaboratively with others in a team environment
• Strong communication skills.
• Adaptable to change

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice

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