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Design Assurance Engineer-Mechanical

Location:Morrisville, NC
Employment Type:Full Time
Description:The design assurance engineer will be responsible for supporting new product development through the application of standard mechanical engineering practices, supplier selection for new components, design verification and validation activities, participating in drawing reviews and performing tolerance stack analyses. This position will also support existing products by supporting major and minor design changes and associated activities. Incumbent must be knowledgeable of design controls and capable of working within a regulated industry.

Promote team environment and continuous improvement. Project a positive and supportive approach to staff and other departments in related areas. Provide support to manufacturing and production staff to achieve company objectives. Interact with all levels of the company to provide status and updates of projects.
Duties:1. Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.
2. Works closely with product development engineering to establish the system design specifications and product requirements.
3. Implement and manage product related programs, including part qualification, inspection and test methodologies, supplier qualification, and maintaining design history documentation.
4. Lead product related tasks in development and manufacturing to ensure processes are capable and quality tools and systems are in place to launch new products. Provide input into IQ/OQ/PQ validation plans and protocols as necessary.
5. Exercises statistical judgment in selecting methods, techniques and evaluation criteria for obtaining results.
6. Supports change control for existing products through review & approval of engineering reports, drawing changes, supplier evaluations, review of biocompatibility and bioburden analysis and design change paperwork.
7. Defines, selects, and applies various techniques including supplier qualification, certification, evaluation, ratings, performance improvements, etc for development and selection of suppliers during the product development process.
8. Define, describe, and use various deployment tools in support of the Quality System in accordance with cGMP and ISO standards.
9. Develops, applies, revises and maintains quality standards for processing materials into partially finished or finished products.
10. Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
11. Analyses product performance data to identify high priority issues relating to safety and customer dissatisfaction.
12. Leads investigative teams to determine root causes of quality issues related to design and manufacturing
13. Investigate, document and implement corrective actions as needed.
14. Use electronic data systems such as Agile, UniPoint and SysPro.
15. All Other Essential Duties as directed.

5+ years in an engineering role, preferably in the medical device or pharmaceutical industry
BS /MS in Mechanical Engineering


Strong statistics background and is data driven.
Experience working with mechanical drawings and GD&T.
Experience working with suppliers.
Exposure to material selection criteria
Exposure to Validations in Medical Device environment would be a plus
Experience with Electro Mechanical or Optical systems would be a plus

Must be able to lift at least 25 lbs

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