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Description

Summary

Seeking a Specialist Engineer Quality with 8+ years of progressive experience in the Medical Device industry, supporting both hardware and software development. This role provides Quality Engineering leadership for product development teams and ensures compliance with regulatory standards.

Primary Duties

+ Lead Quality Engineering activities for software and hardware product development.

+ Manage design control, risk management, and quality processes for new product development.

+ Develop and maintain Risk Management Files (RMF): risk plans, hazard analysis, dFMEAs, pFMEAs, and reports.

+ Review and approve Design History Files (DHF) and related documentation.

+ Oversee product development plans, design inputs/outputs, verification, validation, and test protocols.

+ Provide statistical guidance for design verification and validation.

+ Act as SME for software quality: code reviews, software security, BOM, and best practices.

+ Participate in design reviews across the product lifecycle.

+ Support design transfer and deployment into production.

+ Address anomalies (e.g., bugs, cybersecurity issues) in development and production.

Secondary Duties

+ Lead updates to the Quality System based on new regulations and standards.

+ Resolve and close CAPAs related to design control.

+ Support released products and interface with customer support and account teams.

+ Assist other Quality System areas and perform tasks as assigned by management.

Onsite: 3 days/week or as needed

+ Remote: Open to remote candidates with travel to site as needed

Requirements

Qualifications

Required

+ Experience with FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366.

+ Strong background in design, development, verification, validation, and testing of medical devices.

+ Proficiency in statistical tools and data analysis.

+ Excellent communication and presentation skills.

+ Ability to manage multiple projects and advocate for quality and compliance.

+ Comfortable in a fast-paced, evolving environment.

+ Creative problem-solving skills.

+ Proficient in Microsoft Office, Adobe Acrobat, Minitab, and other business software.

Preferred

+ ASQ CQE certification and/or Six Sigma Black Belt/Green Belt.

+ Experience with AI, AAMI TIR45 framework, and SaMD.

+ Familiarity with cloud infrastructure and AI algorithm development.

Education & Experience

+ Bachelor’s or Master’s degree in Engineering (Biomedical, Software, Electrical, etc.) or equivalent scientific field.

+ Minimum 8 years of Quality Engineering experience in the medical device industry.

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