EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.
• 5 years design assurance/quality assurance experience in a medical device or other highly regulated industry required.

KNOWLEDGE AND SKILL REQUIREMENTS/SPECIALIZED COURSES AND/OR TRAINING:

Working knowledge of ISO and FDA design and development quality requirements.
Technical knowledge in development methodologies, design quality analysis, and project implementation.
Proficiency in assessing manufacturing quality requirements of new product concepts.
Technical knowledge in development methodologies, design, and project implementation, including but not limited to, GD&T & DOE preferred.
Experience in DHF & Technical File structure and maintenance.
Basic knowledge in Electro-Medical safety standards - IEC 60601-1 (Electrical safety), IEC 60601-1-2 (EMC), and other Collateral and Particular standards.
Hands-on experience and knowledge in global medical device regulatory requirements for Electro-Surgical Devices.
Essential knowledge of Risk Management for medical devices (per ISO 14971)

MACHINE, TOOLS, AND/OR EQUIPMENT SKILLS:

Proficiency with PC operations, and the Microsoft Office suite. Hands-on experience with Minitab, SAP, Codebeamer and Windchill preferred.

MATHEMATICAL SKILLS

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

LANGUAGE AND COMMUNICATION SKILLS:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

• Lead design assurance efforts within product design and development for new product introduction projects with an emphasis in quality aspects of integrated software, electrical, and/or mechanical device characteristics, as appropriate for the specific area of position focus.
• For electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in accordance with national and international regulations.
• Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
• Provide active leadership in understanding and implementing regulations/standards, acting as a resource to other disciplines, within the product design process from idealization through product retirement.
• Supervise, assign, and coordinate others / the work of others within the design assurance team to support the department and design projects and goals.
• Provide input into and lead addressing of lessons learned to support development, modification, and improvement of design processes and quality management system.
• Lead product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.
• Display working knowledge and provide guidance to design teams in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance.
• Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
• Lead and coordinate the design assurance aspects of Design to Manufacture Transfer including generation of inspection methods, drawing reviews, determining key product indicators/essential requirements and, where appropriate, training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.
• Ensure required outputs of the design control process are met, including compliance of the design history file (DHF), and support transition of the design project into sustaining engineering.
• Support design-related corrective and preventative activities for projects in the pre-sustaining phase.
• Establish and maintain Risk Management File(s)