Quality Engineer

Sunnyvale  ‐ Onsite
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Keywords

Description

POSITION SUMMARY:

Participates as a team member in the product development process from concept through market introduction on a contract basis for client companies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Performs Quality Assurance tasks related to Product Development projects. Prepares portions of project documents. Edits specifications.

· Investigates and evaluates material biocompatibility and appropriate methods of sterilization, if applicable.

· Designs and implements product and process documentation, including inspection plans.

· Conducts feasibility studies of the design to determine ability to function as intended.

· Conducts risk analysis for products under development.

· Develops verification and validation test protocols.

· Assists in determining schedule and budget requirements.
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE:

· Bachelor's degree in Engineering, or equivalent, is desired.

· 1 to 5 years of medical device product design and development experience, required.

· Demonstrated ability to bring products from concept to market.

· Ability to interact with client companies in a professional manner.

· Familiarity with FDA QSR and ISO 13485 medical device regulations.

· Familiarity with Minitab or similar data analysis package.

· Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

· Possesses effective oral and written communication skills.
Start date
06/2014
From
Real Staffing
Published at
06.06.2014
Project ID:
721991
Contract type
Freelance
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