Responsibility and Authority:

• The Senior Design Quality Engineer has the authority and responsibility for:

• Ensuring that new product development projects and changes to existing products achieve desired product quality levels and are in compliance with all applicable regulatory requirements.

• Ensuring successful transfer of new products from development into production.

• Providing leadership in product risk management throughout entire product lifecycle.

• Assuring internal Design Control policies and procedures comply with regulations and external standards, including risk management and change control.

Scope of Duties / Job Description:

• Review new and modified RF surgical device designs for quality characteristics, including manufacturability, serviceability, testability, performance, usability, reliability, and conformance to product requirements.

• Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.

• Work with external design/test organizations to insure Design Control requirements are fulfilled and appropriate supplier controls are in place.

• Author risk management plans and reports. Lead cross-functional teams in system risk analysis and risk control implementation.

• Create design verification and validation test plans and reports. Manage technicians in test execution.

• Work with Manufacturing Engineering to develop production acceptance criteria, test methods, and process validation protocols.

• Provide engineering expertise and support in supplier and internal auditing, external lab qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.

• Provide training on design-related regulations and external standards.

• Review Design History Files and Technical Files for conformance to applicable requirements.

Working Conditions:

• No medical conditions preventing access to a controlled environment room.

Education / Training:

• B.S. in Electrical Engineering or equivalent experience.

• 5+ years of experience in the Quality Engineering capacity in the medical device industry.

Other Requirements:

• Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.

• Experience applying ISO 14971, IEC 60601-1 and related standards to product design and development.

• Familiarity with industry best practices for fabrication and testing of electrical components and assemblies. Experience with RF electromechanical systems preferred.

• Demonstrated proficiency utilizing quality tools (FMEA, Root Cause Analysis, QFD).

• Skilled in the application of statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments.

• Able to interpret electrical schematics.

• Experience establishing and implementing quality metrics for product development.

• Strong collaboration, negotiation, and conflict resolution skills.

• Excellent verbal and written communication skills.

• ASQ CQE (Certified Quality Engineer) preferred.

• Up to 15% travel.

• Other duties as assigned.