Associate Design Assurance Engineer

Associate Design Assurance Engineer

14 sep
|
Medtronic
|
Departamento de Santa Rosa

14 sep

Medtronic

Departamento de Santa Rosa

The Associate Design Assurance Engineer provides technical quality engineering support to new product development teams focusing on the design related projects, compliance and deliverables required by the Product Development Process (PDP). The Associate Design Assurance Engineer may also provide support to post market design changes/improvements and quality surveillance activities.

Position Responsibilities
• Provide Design Assurance Engineering (DAE) and technical quality support to project teams in the Product Development Process or in support of post market changes
• Provide support and / or execute quality deliverables required by the Product Development Process, Post Market Change Process or Supplier Change Control Process




• Prepare and / or support the creation of design verification test protocols and reports
• Support the execution of all design verification and validation activities including the overseeing testing. Coordinate with all supporting functions (e.g. Test Lab, Microbiology, etc.) to meet project milestones
• Support the execution of all design verification and validation activities, including the determination of statistically relevant sample sizes
• Serve as a quality extended team member on new product development project teams or post market change teams.
• Participate in risk management activities including the creation of the preliminary hazard analysis, Design-FMECA, Post Market Surveillance (PMS) Reports and support risk management document changes due to post market quality activities (PEC, PIA etc)
• Identify and understand design related product failure modes
• Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system
• Support R&D;, Operations, Regulatory Affairs and Component Engineering during all product development phases
• Support the pilot manufacturing line by performing Quality Review and NCMR support
• Provide support for the creation of design control documents, such as specification documents, process instructions, and receiving inspection documents
• Support cross functional pre and post-market root cause analysis teams
• Support design reviews for pre and post market projects
• Support preparation of design dossier and regulatory submissions
• Support the Quality System to achieve FDA facility registration and ISO certification / CE marking
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME:

REQUIRED EDUCATION: 
•  Bachelor’s Degree in Engineering, Bio-engineering or other technical discipline  
REQUIRED YEARS OF EXPERIENCE: 
•  2+ years of similar experience 

DESIRED/PREFERRED QUALIFICATIONS AND SPECIALIZED KNOWLEDGE: 
•  Experience working with medical devices or in a highly regulated environment

Technical
•  Experience and / or proficient with:
•  Statistics, statistical tools and software
•  Process Development, Characterization, and Validation
•  Experience with combination drug/medical device products
•  Able to solve very complex problems that require creativity
•  Microsoft office (Word, Excel, PowerPoint, Visio)

Conceptual
•  Able to deliver on multiple projects simultaneously
•  Ability for reasoning and logical deduction
•  Ability to shift between abstract and concrete concepts

Interpersonal / Leadership
•  Excellent prioritization and verbal/written skills
•  Strong collaboration skills
•  Excellent prioritization and verbal/written skills
•  Self-directed


PHYSICAL JOB REQUIREMENTS: 
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•  While performing the duties of this job, the employee is regularly required to be independently mobile.  
•  The employee is also required to interact with a computer for extended periods of time, and communicate with peers and co-workers.
•  Required to sit or stand for extended periods of time
•  Required to do light lifting up to 25 lbs. 

ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend

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