Principal Design Assurance Quality Engineer

Endovascular Engineering, a portfolio company of Inventure Group, is seeking a Sr/Principal Design Assurance Quality Engineer who will be a key member of product development team. This position will create quality practices to current regulations and standards, and drive all aspects of design control. This position also represents an opportunity to influence the design selection, optimization, specifications, and test development and enable patient safety, quality and reliability in the early designs. This position will play an active role in developing quality management system and ensure QMS compliance adherence.

Position responsibilities (Including, but not limited to)

• Direct and oversees the Design Control documentation (Design History File, Design Reviews)
• Review design control documentation, including but not limited to, requirements, specifications and test methods
• Participate in designing and writing protocols for testing of complex medical device products, such as biocompatibility, sterilization validation, design verification, design validation.
• Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in accordance with ISO 13485 and 21CFR 820.
• Maintain quality system in compliance with all applicable regulatory standards (FDA QSR, ISO 13485, MDR, CMDCAS, Canadian Medical Device requirements) and other relevant requirements throughout the facility
• Support regulatory submissions and on-site audits as Subject Matter Expert (SME)
• Oversee and manage direct report in Document Control
• Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.
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Desired Education & Experience

• Bachelor’s Degree in life sciences, engineering, or equivalent is preferred.
• Proven experience in Design Controls and Risk Management for electromechanical medical devices and/or interventional cardiology products.
• Expertise in biocompatibility, sterilization validation, electronics testing, human factors, or reliability.
• Minimum 10 years related experience in the medical device industry.
• Must have working knowledge of ISO 13485, 21 CFR 820, IEC 60601.
• Excellent written and verbal communications and time management skills required.
• Demonstrated ability to communicate complex topics with a variety of audiences, including technical teams, management, auditors, and non-experts in a clear and effective manner
• Must have a positive attitude with excellent communication, negotiation, and interpersonal skills to maintain a team-oriented environment and develop critical relationships with suppliers.