Sr Design Engineer

Responsibilities

• Lead design verification activities, including development of verification strategies, protocols, test plans, and reports.
• Develop, complete, and optimize product performance, reliability, and safety testing specific to healthcare equipment.
• Analyze verification data using appropriate statistical methods and provide data-driven recommendations.
• Develop test methods, measurement systems, and validation approaches to support verification activities.
• Investigate defects, failures, and design variances using structured root cause analysis techniques.
• Interpret verification results and assess product performance, robustness, and manufacturing stability.
• Support requirements development, traceability, and verification coverage assessments.
• Collaborate with Systems Engineering, RD, Quality, Regulatory, Manufacturing and Operations teams.
• Maintain Design History File (DHF) documentation and ensure compliance with Design Controls and Quality Management System requirements.
• Lead technical reviews, present findings to collaborators, and mentor junior engineers.

Required Skills Qualifications

• Strong experience in Medical Device Verification Validation (VV).
• Knowledge of Design Controls, Risk Management, and regulatory requirements for medical devices.
• Hands-on experience with statistical analysis, DOE, MSA/Gage RR, and data interpretation.
• Proficiency in verification protocol/report development and defect investigation.
• Experience translating product requirements into verifiable test methods and acceptance criteria.
• Familiarity with DFSS, reliability engineering, and DFX principles.
• Working knowledge of Power BI or equivalent data visualization tools.
• Experience with CAD models, engineering drawings, and verification documentation is preferred.
• Excellent technical communication, presentation, and multi-functional collaboration skills.

Preferred Qualifications

• Experience supporting products in US and European regulatory markets.
• Knowledge of ISO 14971, ISO 13485 Design Control requirements, and medical device quality systems.
• Experience leading verification workstreams in new product development or sustaining engineering projects.

Location


Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.