Welcome to Natus Sensory India
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 India are a leading manufacturer of medical devices and software for a range of solutions, including eight sensory nervous systems. 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 system and neural pathways.
Summary
Natus Sensory, Inc. is seeking a
Process Development & Product Engineer to lead and execute engineering activities across
design transfer, process validation, sustaining engineering, and manufacturing integration. This role requires strong technical expertise, ownership of small to mid-scale projects, and effective cross-functional collaboration to ensure product quality and operational excellence. Responsibilities span sustaining support, design transfer, automated test systems, service engineering, quality investigations, risk management, and external manufacturing integration.
Essential Duties And Responsibilities
Design Transfer & New Product Integration (NPI)
- Serve as Process Development Lead (PDL) for NPI projects, driving design transfer activities.
- Collaborate with design teams to develop manufacturing and service strategies for medical devices, including electronic assemblies and optical systems.
- Define service levels, workflows, and repair strategies for new and existing products.
- Act as the primary technical liaison between Natus, contract manufacturers, and service partners.
- Ensure traceability between system, subsystem, process verification/validation, and cross-functional deliverables.
- Develop and source prototypes; establish and complete process Failure Mode Effects Analysis (PFMEA) for manufacturing and service risk management.
- Create and maintain key documentation: Design Transfer Plan, Product Quality Manufacturing Plan, Equipment Specifications, Service Design Transfer Plan, service manual, repair instructions, and troubleshooting guides for new and established products
- Partner with contract manufacturers to develop factory test systems, fixtures, automation tools, and process monitoring systems (e.g., yield and defect tracking).
Process Development & Validation
- Define and execute process validation strategies (IQ/OQ/PQ) and test method validations.
- Create and review Work Instructions, Validation Plans, and protocols.
- Oversee design transfer and validation activities within a GMP environment.
- Support FDA pre-approval and post-approval inspections as a technical expert for design transfer.
Sustaining Engineering & Quality
- Investigate, evaluate, and resolve sustaining issues for released products
- Maintain and improve manufacturing test systems (automated and manual), analyze test data, and support yield improvement initiatives.
- Conduct complaint investigations and root cause analyses, including field service feedback.
- Lead quality system activities: NCRs, CAPAs, SCARs.
- Perform risk analysis and contribute to product and process risk management (such as maintaining Risk Analysis File)
- Contributes to engineering best practices and continuous improvement within quality systems and design controls.
Project Leadership & Collaboration
- Independently lead validation and sustaining activities with minimal supervision.
- Author and maintain technical documentation, including labeling, and leading Design Reviews, and Readiness Reviews.
- Support root cause investigations and corrective actions for quality issues.
- Support agile changes within a GMP environment via routing engineering change orders
- Resolve competing constraints between Operations, Manufacturing, Design, and Service.
- Communicate effectively across engineering, quality, and manufacturing teams
Travel Required: Up to 10%, domestic and international
Education
Education and/or Experience
- Bachelor's Degree in Engineering or Science required.
- 5+ years of experience in medical device manufacturing or development (preferred)
- Experience with process validation, GMP, and GDP.
- Skilled in developing specifications and protocols for verification/qualification activities.
- Strong analytical and problem-solving skills, including statistical process control, design of experiments, measurement system analysis, regression analysis, and hypothesis testing.
- Proven ability to generate consistent, complete technical documentation.
- Project management experience a plus.
- Excellent written and verbal communication skills in English.
Other Duties
Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this position. Duties, responsibilities, and activities may change at any given time, with or without notice.
Compensation and Benefits: Along with a competitive salary and performance-based incentives, we offer a comprehensive benefits package starting from day one, including medical insurance coverage for employees and their families, gratuity as per statutory norms, and paid time off in accordance with applicable labor laws.
Join Natus Sensory today.Confidence in every Sense.
We Offer
- The role will start as a work-from-home remote position but will turn into a physical presence in an office role in Bangalore.
- Minimal travelling: less than 5%
- Collaborative and international environment with different cultures.
- English company language.
- Full ownership of testing of features and functionality.
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.
