BAXTER is hiring | Multiple Positions | Graduate or post-graduate in Mechanical/ Electrical/ Electronics/ Biomedical Engineering |

Position – Sr Eng, Quality Assurance

BAXTER
Location – Bengaluru, Karnataka

Exp. – 4 to 10 years

Job description

• Demonstrate quality assertiveness and can represent the Quality function in various roles such as product support and lifecycle management.
• Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
• Support Risk Management activities for sustaining engineering projects.
• Support post market activities such as complaint investigation, complaint trending, CAPA, and FCA processes
• Assist in decision making for process improvement efforts
• Support global Renal manufacturing facilities and associated manufacturing and supplier changes
• Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries

Qualifications

• BS Engineering (Mechanical or Electrical engineering preferred) and 4-10 years in related Quality or Engineering field in the medical products industry.
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred Strong interpersonal/communication/influencing/negotiation skills.
• Strong analytical and problem-solving skills.
• Working knowledge of FDA Regulations
• Demonstrated ability to lead others within a small project or investigational environments
• Good technical overview of medical device verification and validation
• Good understanding of FDA QSR Part 820, ISO 13485, EU MDD / EU MDR
• Broad working knowledge of Medical Device Software Development Life cycle and IEC 62304
• Basic understanding of medical device manufacturing process
• Good Understanding of requirements for Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation.
• Reasonable Accommodations

Position – Sr Eng, Systems

BAXTER
Location – Bengaluru, Karnataka
Exp. – 6+ years

Job description

• Interact with customers, marketing, clinical experts to develop and refine user requirements.
• Ensure user needs are captured, quality requirements are met and technical risks are mitigated
• Lead the development and documentation of the product systems architecture and system-level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
• Knowledge of standards, regulations, product safety, and compliance requirements, risk management for the development of safety-critical systems. Prior experience in end to end product development of medical devices is a plus.
• Manage the integration of deliverables from sub-system design teams and external partners.
• Resolve competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to the market.
• Plan and execute system integration activities to minimize issues in systems validation.
• Develop test plans, test protocols, and test reports for product integration testing.
• Document traceability from requirements to verification activities, and from requirements to design entities.
• Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.
• Develop and maintain an effective and corroborative working relationship with internal and external development partners.
• Communicate design requirements and provide technical guidance to suppliers as needed.
• Provide leadership to effectively transition the product to manufacturing and ensure robust products and manufacturing processes.

Qualifications

• Graduate or Post Graduate in Electronics, Electrical, Mechanical, Biomedical or related Engineering. An advanced technical degree is desired. Experience should include at least 6-10 years of relevant technical experience, including technical leadership. Prior experience with Infusion pumps is a plus.
• Good knowledge of engineering disciplines and solid knowledge of related disciplines, Electro/Mechanical, Systems, Fluid Mechanics, Materials Science, etc. A good overview of device connectivity, software applications for medical devices is a plus.
• A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated product/systems such as aerospace or military hardware
• Have a proven track record of management/leadership effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.
• Reasonable Accommodations

Position – Principal Eng, Design Transfer Lead

BAXTER
Location – Bengaluru, Karnataka
Exp. – 10+ years

Job description

• Develop product control specifications and system configurations/bill of materials.
• Contributing to manufacturing work instructions and build protocols, preventive maintenance procedures, and service procedures.
• Ensure appropriate traceability between system, subsystem, verification/validation, and cross-functional deliverables
• Resolve competing constraints between interrelated functions Manufacturing and Service
• Familiarity with medical devices, manufacturing process development, and process validation preferred
• Familiarity with DOORs, HP ALM, TCU, JIRA preferred
• Must possess strong engineering knowledge and experience in disciplines and design principles in electromechanical devices, preferably Medical Devices or other regulated industry.
• Should own the product BOM & should have good knowledge of product configuration management.
• Should have owned in the past proto & verification builds.
• Should have worked on should costing for BOM & related tools.
• Requires strong organization and polished communication skills, with the ability to interface with both technical and non-technical personnel throughout the organization.
• Hands-on experience in product development for at least 3 years in a career.
• Good exposure to Solidworks & Solidworks EPDM.

Qualifications

• A graduate or a post-graduate in Mechanical Engineering and 10 to 12 years of related experience. Prior experience in the medical device domain is a plus.
• Reasonable Accommodations

Position – Principal Eng, Systems

BAXTER
Location – Bengaluru, Karnataka
Exp. – 12+ years

Job description

• Interact with customers and marketing to develop and refine user requirements.
• Communicate design requirements and provide technical guidance to suppliers as needed.
• Ensure user needs are captured, quality requirements are met and technical risks are mitigated
• Lead the development and documentation of the product systems architecture and system-level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
• Develop the Risk Management Plan and execute the Risk Management activities defined by the plan.
• Manage integration of deliverables from sub-system design teams and external partners.
• Resolve competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to the market.
• Plan and execute system integration activities to minimize issues in systems validation.
• Develop test plans, test protocols, and test reports for product integration testing.
• Document traceability from requirements to verification activities, and from requirements to design entities.
• Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.
• Develop and maintain an effective and corroborative working relationship with internal and external development partners.
• Provide leadership to effectively transition the product to manufacturing and ensure robust products and manufacturing processes.

Qualifications

• Graduate or Post Graduate in Electrical, Mechanical, Biomedical or related Engineering. An advanced technical degree is desired. Experience should include at least 12-16 years of relevant technical experience, including some technical leadership. Prior experience in the Renal device domain is a plus.
• Must possess a strong knowledge of engineering disciplines and solid knowledge of related disciplines, Electro/Mechanical, Systems, Fluid Mechanics, Materials Science, etc.
• A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware.
• Have a proven track record of management/leadership effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.
• Reasonable Accommodations

Position – Sr Principal Eng, Mechanical

BAXTER
Location – Bengaluru, Karnataka
Exp. – 13+ years

Job description

• Defines design requirements and hardware specifications based on customer or user requirements.
• Contributes to development and documentation of mechanical system architectures.
• Lead the creation and development of designs of complex mechanical assemblies, mechanisms, and component parts for electro-mechanical medical devices meeting performance objectives.
• Adept knowledge on Plastics Injection Molding, Sheetmetal & casting part designs as per mfg. guidelines. Strong knowledge on DFM, DFA is needed.
• Good knowledge on tooling & should have worked with tool developers.
• Good knowledge on good engineering drawing practices.
• Worked on Electromechanical devices.
• Perform in-depth mechanical analysis and calculations including tolerance analysis, load and fatigue life analysis, and thermal and heat transfer modeling to ensure consistent performance in safety critical applications.
• Good knowledge & experience on FEA tools like Ansys, Abacus (Structural- Linear/Non-linear).
• Ensures successful integration of mechanical design elements with electrical and consumable components.
• Completes deliverables related to integration of designs from sub-system design teams and external partners.
• Leads troubleshooting and problem solving efforts related to mechanical aspects of the design and interfaces with other design constituents.
• Ability to convert scope to requirements & develop project plans.
• Able to effectively transition products to manufacturing and ensure robust products and manufacturing processes.
• Improves mechanical and electro mechanical designs to optimize for production, reliability, regulatory compliance and cost.
• Ability to identify risks in design, programs & come up with mitigation plan.
• Resolves competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
• Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s).
• Creates and communicates design/test plans, tasks, deliverables and status. Manages time and resources to meet committed schedule milestones.

Qualifications

• A graduate or a post graduate in Mechanical Engineering and 13-17 years related experience. Prior experience in the infusion pump domain is a plus.
• Good knowledge on Agile methodology (scrum) is added advantage.
• Individual should have gone through full product life cycle from concept to post market handling.
• Working knowledge on tooling is preferred / tool designer.
• A demonstrated track record in electromechanical hardware development, preferably medical devices or other highly regulated product domain such as aircraft/automotive/defense industries.
• A proven track record of effectiveness in a fast-paced environment.
• Knowledge and experience using CAD systems for mechanical design and analysis (Solidworks, preferred).
• Knowledge of standards such as IEC 60601, ANSI and ASTM preferred.
• Proven ability to create results within budget, timeline, and product/project deliverables.
• Reasonable Accommodations