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This design assurance engineer position supports product 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.
Job Responsibility:
Executes and supports completion of product development deliverables
Creates and supports development of DHF 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
Implements appropriate sampling inspection and supports qualification activities for purchased components
Supports design test method development, and leads method validation activities
Utilizes statistical techniques to lead and support characterization, verification, and validation testing and root cause analysis
Support quality system related deliverables including nonconformances and CAPAs
Perform other related duties and responsibilities, as assigned
Requirements:
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 investigating and implementing Corrective and Preventive Actions
Experience in design controls and test method 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
What we offer:
Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts