MEDICAL DEVICE Sr 1 Quality Design Engineer
Seeking a Design QA Engineer who will work directly with the Design Engineering team. You would be responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering or Engineering Technology will be essential for this position.
Essential Duties and Responsibilities:
- 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 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 the work of others within the design assurance team to support design projects meet the appropriate goals.
- Drive development, modification, and improvement of design processes and quality management system based on gap analysis or lessons learned.
- 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 throughout the lifecycle of the product design.
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.
7.5 % bonus