Senior Design Assurance Engineer

Specific Design Assurance project activities include:

• Work with the team to identify appropriate customer requirements for the product.


• Work with the team to identify product specifications that correctly define the product.


• Define the risk management approach.


• Facilitate product risk analysis from a design and process perspective.


• Provide insight and direction to appropriate inspection of materials.


• Define with the team appropriate testing and develop the test plans.


• Analyze testing results and confirm that our products meet the requirements set forth.


• Provide clear concise documented evidence of the quality of our product to regulatory bodies.


• Provide scope, deliverables planning, and timelines to the project for planning and subsequent management of product assurance deliverables to meet project timelines.


Specific Packaging project activities include:
Work with the product development team to identify packaging specifications.

• Develop packaging concepts.


• Work with external vendors to develop packaging concepts.


• Define testing requirements and facilitate testing.


• Create plans and reports.


Additional activities include:

• Assist in the development of QA/QC policies and procedure to ensure department efficiency and compliance to appropriate regulations.


• Conduct training as needed on design assurance methodology, concepts and tools.


• Support the quality objectives of other engineering disciplines within product development as needed.


Qaualifications:

• BS degree in Engineering or related field.


• Preferred work experience of 5-7 years in Product(Design) Assurance Engineering.


• Preferred experience of at least 2 years in conducting product risk analysis.


• Knowledge and application of QSR, ISO and other applicable international regulations.


• Knowledge and application of mechanical measurement systems, measurement techniques and process capability studies.


• Ability to read mechanical drawings, understand geometric dimensioning & tolerancing and design appropriate inspection methods to ensure design intent is maintained.


• Ability to interact effectively with a cross-function team.


• Ability to facilitate meetings.


• Computer efficiency in Microsoft programs relevant to job responsibilities.


• Ability to constructively interact with a range of personalities at many levels of the organization.


• Experience in medical device industry preferred.
  
  

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We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.

An Equal Opportunity / Affirmative Action Employer

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