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Design Controls Systems Engineer

Sunnyvale, CA
Amick Brown is seeking an experienced Design Controls Systems Engineer for our direct client.

Location: Sunnyvale, CA 94086.               
Duration: 12 Months with possible extension.


Description:
 
  • We are seeking a Design Controls Systems Engineer to support the team focused on new product development tools and process.
  • The Design Controls Systems Engineer will help plan, define, develop, verify, and deploy new tools in compliance with established Design Control applicable standards and regulations.
  • The ideal candidate is quality-focused self-starter with an attention to detail and a passion for helping teams innovate and deliver fully documented solutions in support of our medical devices.
  • The candidate has a strong understanding of Medical Device regulations and experience implementing compliant requirements management and/or test management processes and automation tools.
 
Roles and Responsibilities:
 
  • Working with cross-functional teams to solve problems and execute improved tools and processes.
  • Ability to work with cross-functional teams to identify gaps, root cause, propose solutions, and actions that are compliant with standards/regulations and presenting optimized solutions for end users.
  • Documentation and verification testing for Requirements and Test Management automation systems
  • User support for complex documentation for regulatory submissions
  • Test case development, execution, and documentation for computer software verification.
 
Skill/Job Requirements:
 
  • Understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
  • Requirements Management excellence including how to translate technical details into unambiguous, testable, reusable requirements and specifications
  • Strong communicator and relationship builder
  • Detail-oriented and Quality focused
  • Excellent investigative skills
 
Qualifications:
 
  • Bachelor’s Degree preferred.
  • 5+ years of previous related experience in medical device development, requirements management, test management, and/or regulatory documentation
  • Experience with Application Lifecycle Management tools (Siemens Polarion, PTC Integrity, Doors)
  • Excellent verbal and written communication skills
  • Excellent planning and time management skills
  • Highly proficient in Word, Excel, Visio, and PowerPoint
  • Proficiency in Oracle/Agile helpful
 
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

Regular full-time employees are eligible for the following Amick Brown provided benefits: 
  • Health
  • Vision
  • Dental
  • 401k with company match
  • Paid time off
  • Sick Leave
  • Short-Term Disability
  • Life Insurance
  • Wellness & Discount Programs
 
 

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