Design Assurance Engineer II
Teleflex

Job Order #: 16928121

Chelmsford, MA 01824

Full Time

40 hours per week

POSTED 6/2/2022

EXPIRES 8/31/2022

Job Description

Position Summary
-    Fulfill design assurance role on new product development (conception to launch) and sustaining projects
-    Complete planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
-    Support Regulatory Affairs with creating submissions and responding to submission questions.
-    Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
-    Continued support and optimization of DA centric New Product Development deliverables and processes.


Principal Responsibilities
-    Participate and lead New Product Development Phase Reviews and Design Reviews.
-    Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
-    Create and support the development and validation of new test methods.
-    Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
-    Develop the strategy and manage the execution of design verification and validation.
-    Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
-    Develop, execute, and manage First Article inspections.
-    Provide direction to design assurance engineering technicians supporting assigned projects.
-    Support improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
-    Support regulatory approvals and responses to regulatory questions.
-    Support Sustaining Engineering for design and process changes to commercialized product.
-    Support the transfer of new product development projects from development to production.
-    Support internal and external audits.


Education / Experience Requirements
-    BA/BS in Engineering or physical sciences required.
-    Two years of related experience required.


Specialized Skills / Other Requirements
-    Ability to work independently and with general direction.
-    Ability to define, organize, and manage individual and team based tasks.
-    Provide direction to extended team members.
-    Effective verbal and written communication.
-    Proficient in technical report writing and review.
-    Interpersonal skills; working in a team and as an individual contributor.
-    Structured and methodical problem-solving approach.
-    Basic understanding of design controls, risk management, statistics, test method validation, and new product development processes.
-    Basic understanding of industry regulations such as ISO13485 and FDA QSR's.

How To Apply

Please email your resume to thavrith.thao@masshirelowellcc.com for consideration

Address

16 Elizabeth DRIVE
Chelmsford, MA 01824

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Shift

First

Not Specified

Per Diem Position

Not Specified

Union Position

No

Apprenticeship

No

Pay

Not Specified

Benefits

  • Benefits Unknown

Benefit Details

Name

Thavrith Thao

Title

Business Services Representation

Email

thavrith.thao@masshirelowellcc.com

Phone

978-805-4875

Address

107 Merrimack Street
Lowell, MA 01852

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