Natus Medical Incorporated
Website:
natus.com
Job details:
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.
Job Title: Design Assurance Engineer
Department: Quality & Regulatory Affairs
Reports To: Quality Assurance Manager
Location: Bangalore- Hybrid
Position Type: Full-Time
Position Summary
We are seeking an experienced Design Assurance Engineer to play a critical role in ensuring the safety, efficacy, and compliance of our portfolio of Class I & Class IIa medical devices. In this role, you will serve as the core design quality representative on cross-functional product development teams, guiding projects from concept through commercialization. You will ensure that design controls, risk management, and verification/validation activities comply with ISO 13485, EU MDR (2017/745), and US FDA 21 CFR Part 820 regulations.
Key Responsibilities
- Design Controls: Lead and support cross-functional teams in the establishment, execution, and documentation of Design Controls, including design inputs, design outputs, design reviews, and design transfer.
- Risk Management: Author and maintain Risk Management Files (including Hazard Analyses, dFMEAs, and pFMEAs) in strict accordance with ISO 14971, ensuring risks are mitigated to acceptable levels.
- Verification & Validation: Review and approve design verification and validation (V&V) protocols and reports, ensuring statistical rationale and sample sizes are technically sound and compliant.
- Technical Documentation: Author, review, and maintain the Design History File (DHF) and contribute directly to Technical Documentation required for CE marking under EU MDR and 510(k) submissions.
- Cross-Functional Collaboration: Partner closely with R&D, Regulatory Affairs, and Manufacturing to ensure smooth design transfer and that production processes are capable of meeting design specifications.
- Change Control: Evaluate design and process changes post-launch to assess their impact on product safety, performance, and regulatory status.
- Continuous Improvement: Support CAPA (Corrective and Preventive Action) investigations, root-cause analyses, and audit readiness activities.
Qualifications & Experience
- Education: Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical), Life Sciences, or a related technical discipline.
- Experience: Minimum of 4–5 years of quality or design assurance engineering experience specifically within the medical device industry.
- Regulatory Knowledge: Deep understanding of medical device regulations, specifically focusing on Class IIa/Class II frameworks, including ISO 13485, ISO 14971, EU MDR 2017/745, and FDA 21 CFR Part 820.
- Technical Skills: Strong experience with statistical analysis techniques (e.g., sample size determination, ANOVA, capability analysis) and risk management methodologies.
- Soft Skills: Excellent technical writing skills, a proactive problem-solving mindset, and the ability to communicate complex quality requirements clearly to technical and non-technical stakeholders.
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.
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