Sr Design Assurance Engineer

Main Objective:

Responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer and post-market surevillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals.

Essential Duties and Responsibilities:

1. 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.
2. For electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in accordance with national and international regulations.
3. Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
4. 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.
5. Supervise, assign, and coordinate others / the work of others within the design assurance team to support the department and design projects and goals.
6. Provide input into and lead addressing of lessons learned to support development, modificiation, and improvement of design processes and quality management system.
7. 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.
8. Display working knowledge and provide guidance to design teams in the area of usability/human factors engineering priniciples including standards (IEC 62366) and FDA guidance for compliance.
9. Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
10. 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.
11. 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.
12. Support design-related corrective and preventative activities for projects in the pre-sustaining phase. 

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

• Bachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.
• 7 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.

Machine, Tools, and/or Equipment Skills:

Proficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software.  Hands on experience with SAP and Agile preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.