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Design Controls Systems Engineer

Job Description

Title:Design Controls Systems Engineer (Contract)
Location: Sunnyvale CA
Duration: 7 Months

Primary Function of Position:
We are seeking a Design Controls Systems Engineer to support the Intuitive Surgical team focused on new product development tools and processes. The Design Controls Systems Engineer will help develop, verify, and deploy new tools in compliance with established Design Control, Quality, and IT processes. The ideal candidate is quality focused with an attention to detail and a passion for helping teams innovate and deliver fully documented medical devices to market in record time. The candidate has a strong understanding of Medical Device regulations and experience implementing compliant requirements management and/or test management processes and automation tools. The position includes:

Working with cross functional teams to solve problems and execute improved tools and processes
Assisting in authoring and ECO release of documents needed to support additional functionality in ALM tool (test execution and migration of content)
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:
Bachelors 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 such as Siemens Polarion, PTC Integrity, and 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

Job Requirements

 

Job Snapshot

Location US-CA-Sunnyvale
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type IT & Technical
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-Sunnyvale
Fasheeulla Khan
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Snapshot
Ascent
Company:
US-CA-Sunnyvale
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
IT & Technical
Store Type:

Job Description

Title:Design Controls Systems Engineer (Contract)
Location: Sunnyvale CA
Duration: 7 Months

Primary Function of Position:
We are seeking a Design Controls Systems Engineer to support the Intuitive Surgical team focused on new product development tools and processes. The Design Controls Systems Engineer will help develop, verify, and deploy new tools in compliance with established Design Control, Quality, and IT processes. The ideal candidate is quality focused with an attention to detail and a passion for helping teams innovate and deliver fully documented medical devices to market in record time. The candidate has a strong understanding of Medical Device regulations and experience implementing compliant requirements management and/or test management processes and automation tools. The position includes:

Working with cross functional teams to solve problems and execute improved tools and processes
Assisting in authoring and ECO release of documents needed to support additional functionality in ALM tool (test execution and migration of content)
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:
Bachelors 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 such as Siemens Polarion, PTC Integrity, and 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

Job Requirements

 
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Design Controls Systems Engineer Apply now