Design Controls Engineer

Amick Brown is seeking an experienced Design Controls Engineer for our direct client.

Location: Raleigh, NC

Duration: 9 months

Estimated pay range: $40 - 50 per hour per client contract and candidate skills, experience and work location.

Job Description

Roles & Responsibilities

Responsibilities

• Assist the new product development team with compiling and updating of engineering design control documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation.
• Assist the cross functional new product development team with architecting a holistic documentation/tracing structure that is easily maintained.
• Support design team to produce high quality, consistent design documents that meet clients design control processes.
• Use the requirements management database tool extensively to manage design control documents, and the links between document content.
  
  

Activities

• Assist subject matter experts with writing, reviewing, and/or editing documents required by clients design control process, including requirements, risk analyses, specifications, test protocols, and design review checklists.
• Coordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.
• Produce requirements trace mapping and associated documentation.
• Use Siemens Polarion as a tool to accomplish the following: Enter and edit documents.
• Create and edit requirements and test cases.
• Create trace links
• Produce reports using standard report templates. Create additional custom reports as needed.
• Produce trace reports.
• Use Agile as a tool to accomplish the following: Organize and structure Design History Files (DHF) using Design Control checklists.
• Prepare and submit ECOs for individual documents and for DHF Bill of Material (BOM) changes.
• Work with the Technical Publications department to assure that Manuals, Instructions for Use, Labels and Training Materials are consistent with design documentation. Create trace documents and protocols used to assist in this process.
  
  

Skills, Experience, Education, & Training

• Minimal Requirements
• Bachelor’s Degree in engineering or other technical area
• Ability to understand complex technical information and translate into writing
• Proven success recognizing critical issues with the ability to react quickly under pressure and drive issues to closure by providing coordinated direction.
• Ability to manage challenging assignments and multiple assignments in parallel
• Strong planning, decision making, negotiating and change management skills
• Assertive, outgoing personality with an ability to work collaboratively within an engineering team
• Excellent writing and communication skills, and attention to detail
• Skilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat
  
  

Preferred Requirements

• Minimum 8 years experience working in an ISO 9001 medical device product development environment or other regulated industry
• Experience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports
• Skilled in the use of Agile or similar lifecycle management system tool
• Skilled in the use of Integrity, Polarion or other requirements management tool
• Development experience with complex systems with a combination of hardware and software
• Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs)
  
  

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
• Long -Term Disability
• Life Insurance
• Wellness & Discount Programs