Senior Design Assurance Engineer

Basic Function

This Design Assurance Engineer position supports product and process development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality initiatives. This position interacts closely with the Engineering team as well as Operations, Quality Systems, Quality Assurance, Marketing, and Regulatory. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Essential Functions:

• Executes and supports completion of product and process development deliverables
• Creates and supports development of DHF and DMR to ensure content is complete, accurate, and compliant with regulatory standards
• Supports the development and maintenance of customer requirements, product requirements, and product specifications
• Collaborates cross-functionally to lead and support completion and maintenance of product risk management deliverables
• Authors design verification and design validation plan and report documents
• Supports the development of manufacturing processes, equipment, and product inspection documentation for new products
• Authors process validation plan and report documents
• Implements appropriate sampling inspection and supports qualification activities for purchased components
• Supports design and process test and inspection method development, and leads method validation activities
• Utilizes statistical techniques to lead and support characterization, verification, and validation testing and root cause analysis
• Leads and supports completion of risk management deliverables to establish and maintain safe and effective products and processes
• Support quality system related deliverables including nonconformances and CAPAs
• Perform other related duties and responsibilities, as assigned.

Qualifications:

• Bachelor of Science in engineering
• 5+ years’ experience in Engineering or Quality in the medical device industry.
• Must be able to work independently under limited supervision.
• Advanced knowledge of basic Quality Systems and good documentation practices.
• Experience in Non-Conforming Material Reporting
• Experience in investigating and implementing Corrective and Preventive Actions
• Experience in design controls, and test method and process validation
• Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
• Strong communication skills, both verbal and written.
• Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
• Requires typing, talking and hearing.
• Travel <10%