Design Assurance Engineer

Design Assurance Engineer

Job Summary

We are seeking a highly motivated Design Assurance Engineer to support the development, commercialization, and sustaining of innovative medical device products. The role will provide Design Assurance expertise throughout the product lifecycle, ensuring that products are developed and maintained in compliance with applicable regulatory requirements, quality system procedures, and industry standards.

The position will work closely with R&D, Engineering, Quality, Regulatory Affairs, Operations, Manufacturing, Clinical, and other cross-functional teams to ensure robust application of design controls, risk management, verification and validation, and design documentation.

Key Responsibilities

Design Assurance & Design Controls

• Provide Design Assurance support throughout the product development lifecycle, from concept and design inputs through verification, validation, design transfer, commercialization, and sustaining activities.
• Ensure effective implementation of design control processes in accordance with applicable quality system and regulatory requirements.
• Review and provide technical input on design inputs, design outputs, design reviews, development plans, specifications, and other design-control deliverables.
• Ensure traceability between user needs, design inputs, design outputs, risks, and verification/validation activities.
• Support preparation, review, and maintenance of Design History Files (DHF) and other product technical documentation.
• Participate in design reviews and provide independent assessment of product quality, safety, reliability, and compliance.

Risk Management

• Lead or support product risk-management activities in accordance with ISO 14971 and applicable regulatory requirements.
• Facilitate and/or participate in Design FMEA, Process FMEA, hazard analysis, fault-tree analysis, and other risk assessment activities.
• Evaluate identified risks and ensure appropriate risk-control measures are incorporated into product designs.
• Review risk-control implementation and effectiveness through objective evidence.
• Maintain risk-management documentation throughout the product lifecycle.

Verification & Validation

• Develop, review, and approve risk-based verification and validation strategies, protocols, and reports.
• Support development of test methods, acceptance criteria, sample-size rationale, and statistical approaches where applicable.
• Review verification and validation results to ensure design requirements have been adequately demonstrated.
• Support design verification, design validation, usability/human factors activities, software validation, and process validation as applicable to the product.
• Identify gaps, inconsistencies, or potential compliance risks within V&V activities and drive appropriate resolution.

Regulatory & Compliance

• Ensure product development activities comply with applicable regulatory requirements and industry standards.
• Support compliance with applicable requirements including ISO 13485, ISO 14971, FDA regulations, and relevant IEC/ISO standards.
• Provide Design Assurance support for regulatory submissions, audits, inspections, and responses to regulatory questions.
• Evaluate the impact of regulatory and standards changes on product development and sustaining activities.
• Support objective evidence generation for regulatory and quality-system requirements.

Sustaining Engineering & Product Lifecycle

• Provide Design Assurance support for product changes, CAPA, nonconformances, complaints, supplier changes, and post-market activities.
• Perform or support design-change impact assessments, including evaluation of potential effects on product risk, verification/validation, regulatory requirements, and design documentation.
• Participate in root-cause investigations and development of corrective and preventive actions.
• Ensure appropriate verification or validation is performed following design changes.
• Support continuous improvement of product quality, reliability, and design-control processes.

Cross-Functional Collaboration

• Partner with R&D and Engineering teams to ensure quality and regulatory requirements are incorporated early in the development process.
• Collaborate with Quality, Regulatory, Manufacturing, Operations, Clinical, and Supplier Quality teams to resolve technical and compliance issues.
• Provide Design Assurance guidance and coaching to project teams.
• Effectively communicate technical risks, project status, and quality concerns to stakeholders and leadership.
• Work with external laboratories, suppliers, and consultants when required.

Required Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Quality Engineering, or a related technical discipline.
• Typically 3–7 years of relevant experience in medical devices, healthcare products, pharmaceuticals, or another highly regulated industry.
• Hands-on experience with Design Controls, Risk Management, Verification & Validation, and technical documentation.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience with Design FMEA, risk assessments, design reviews, and product development processes.
• Experience reviewing or developing engineering/design documentation and test protocols/reports.
• Strong analytical, problem-solving, technical writing, and communication skills.
• Ability to work effectively in a highly cross-functional and matrixed organization.

Preferred Qualifications

• Experience with FDA 21 CFR Part 820 / Quality System Regulation and applicable global medical-device regulations.
• Knowledge of IEC 60601, IEC 62304, IEC 62366, or other product-specific standards.
• Experience with software, electrical, mechanical, or electromechanical medical devices.
• Experience supporting regulatory submissions, audits, or health-authority inspections.
• Experience with statistical analysis, DOE, capability analysis, MSA, or other quality-engineering methodologies.
• Familiarity with tools such as JMP, Minitab, statistical analysis software, or electronic quality/document management systems.
• ASQ, Six Sigma, or other relevant professional certification is a plus.

Core Competencies

• Design Assurance & Design Controls
• Risk Management & FMEA
• Verification & Validation
• Regulatory Compliance
• Quality Engineering
• Root Cause Analysis & Problem Solving
• Technical Documentation
• Risk-Based Decision Making
• Cross-Functional Collaboration
• Project Management
• Strong Written & Verbal Communication

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com

Regards

Niraj kumar