Product Documentation & CAD Engineer

JOB TITLE:Product Documentation & CAD Engineer  

Welcome to Natus We are continuing to grow our business in India and are now looking to expand our team there. Be part of this exciting journey right from the start!Natus Sensory is a leading manufacturer of medical devices and software for a range of solutions. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. We manufacture and distribute a range of medical device products used in the diagnosis of human disorders of sensory systems. 

About The role: The Product Documentation & CAD Engineer, within our R&D department, will be responsible for supporting product sustaining, New Product Introduction (NPI), engineering documentation, configuration management, and CAD activities for new and existing medical device products. In this role, you will collaborate with cross-functional teams to maintain accurate product configurations, engineering drawings, Bills of Materials (BOMs), and controlled product documentation throughout the product lifecycle.

You will work closely with R&D, Manufacturing, Quality, Regulatory, and Supply Chain teams to execute engineering changes, support design transfer and manufacturing readiness, resolve product and component-related issues, and ensure alignment between product designs and released documentation. The role requires strong hands-on experience with Agile PLM, SolidWorks CAD, EPDM/PDM, Jira, BOM management, and engineering change control within a structured product-development environment. 

Essential duties and responsibilities:

Product Sustaining and Lifecycle Engineering:

• Support sustaining engineering activities for released medical devices, including product improvements, component and supplier changes, obsolescence management, cost reduction, manufacturing improvements, and product lifecycle updates.
• Investigate product, component, supplier, and manufacturing issues and collaborate with cross-functional teams to identify root causes and implement robust engineering solutions.
• Support design modifications and product improvements while maintaining compliance with approved product requirements, design controls, risk management, and configuration management processes. 

CAD, Engineering Drawings, and Product Configuration:

• Create, modify, and maintain 3D models, assemblies, and 2D engineering drawings using SolidWorks CAD, ensuring appropriate dimensions, tolerances, materials, specifications, and revision control.
• Maintain engineering drawings, CAD models, assemblies, and associated design files within EPDM/PDM, ensuring data integrity, traceability, revision control, and proper release.
• Create and maintain part numbers, manufacturer part numbers, product structures, Bills of Materials (BOMs), and related product configuration data within Agile PLM.
• Ensure alignment and traceability between BOMs, CAD models, engineering drawings, specifications, approved manufacturer parts, and released product documentation. 

Engineering Change and Configuration Management:

• Initiate, develop, route, and support engineering change activities, including ECOs, DCOs, and MCOs, from initiation through review, approval, release, and implementation.
• Perform change-impact assessments and coordinate with R&D, Manufacturing, Quality, Regulatory, and Supply Chain to ensure changes are complete, accurate, properly documented, and effectively implemented.
• Maintain configuration integrity throughout the product lifecycle and ensure engineering records comply with company procedures, document-control requirements, and applicable regulatory standards. 

New Product Introduction and Design Transfer:

• Support NPI and design transfer activities, including BOM readiness, drawing and specification release, product configuration, engineering change implementation, manufacturing documentation, and production readiness.
• Partner with R&D and Manufacturing teams to transition designs from development into production while ensuring released documentation accurately reflects the approved product configuration.
• Support prototype builds, pilot builds, first-article activities, manufacturing readiness reviews, and resolution of engineering issues identified during NPI. 

Cross-Functional Collaboration and Project Execution:

• Collaborate closely with R&D, Manufacturing, Quality, Regulatory, Supply Chain, and Operations teams to support product development, sustaining engineering, and manufacturing objectives.
• Participate in design reviews, engineering change reviews, product lifecycle reviews, and project meetings to ensure technical and documentation alignment across functions.
• Track engineering tasks, issues, and project activities using Jira, ensuring timely execution and clear communication of status, risks, and dependencies.
• Coordinate effectively with U.S.-based and global engineering teams and provide working-hour overlap as required to support project execution and cross-functional collaboration. 

Qualifications • Education & Experience

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Production Engineering, Mechatronics Engineering, or a related engineering discipline.
• Minimum of 5–10 years of relevant engineering experience in product engineering, sustaining engineering, mechanical design/CAD, NPI, engineering documentation, or configuration management.
• Experience supporting medical devices or another regulated product-development environment is preferred. 

CAD & Product Lifecycle Management Expertise

• Proficiency in SolidWorks CAD, including 3D modeling, assemblies, 2D engineering drawings, drawing revisions, and engineering documentation.
• Hands-on experience with Agile PLM, including part creation, manufacturer part management, BOM creation and maintenance, product structures, and engineering change activities.
• Experience with EPDM/PDM or comparable engineering data and document-management systems.
• Strong ability to read and interpret engineering drawings, dimensions, tolerances, material specifications, and manufacturing requirements.

Configuration Management & Engineering Change Control

• Working knowledge of product configuration management, BOM management, document control, revision control, and engineering release processes.
• Experience initiating and executing ECOs, DCOs, MCOs, or equivalent engineering change processes.
• Understanding of product lifecycle management principles and maintaining traceability between engineering designs, BOMs, specifications, approved components, and manufacturing documentation.

NPI, Sustaining & Regulated Product Development

• Experience supporting New Product Introduction (NPI), design transfer, sustaining engineering, and manufacturing readiness activities.
• Experience supporting component changes, supplier changes, product improvements, obsolescence, and manufacturing-related engineering changes.
• Familiarity with medical device quality systems, ISO 13485, FDA Quality System requirements, design controls, and configuration management practices is desirable.

Project Management & Communication Skills

• Experience using Jira or similar tools for engineering task, issue, and project tracking.
• Strong organizational, analytical, and problem-solving skills with exceptional attention to detail and documentation accuracy.
• Ability to independently manage multiple engineering changes and documentation activities while meeting project schedules and quality requirements.
• Effective written and verbal communication skills with the ability to collaborate across global and cross-functional engineering teams.

Desirable Additional Skills

• Experience with GD&T (ASME Y14.5) and tolerance analysis.
• Knowledge of DFM/DFA principles and manufacturing processes such as machining, injection molding, sheet metal, and assembly.
• Experience supporting root-cause investigations, CAPA activities, supplier changes, and component obsolescence.
• Familiarity with risk management and design-control processes for regulated medical devices.
• Experience supporting prototype, pilot, and production builds.
• Ability to apply product lifecycle, configuration management, and engineering change-control processes independently.

We offer

• The role is a work hybrid position but can turn into a physical presence in an office role in Bangalore, India.
• The position supports teams based in the United States and requires regular working-hour overlap.
• The candidate must be able to provide coverage within approximately 7:00 AM – 1:00 PM U.S. Central Time (CST), with actual working hours varying within this range based on project and team requirements.
• Minimal travelling: less than 5%.
• Collaborative and international environment with different cultures.
• English company language. 

EEO Statement:Natus Sensory is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.