Amick Brown is seeking an experienced Design Controls Engineer for our direct client.
Location: Santa Clara, CA
Duration: 12 Months
The Design Controls Engineer plays a vital role in developing safe and effective medical devices at the place. As an embedded member of the New Product Development (R&D) team, they support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created and maintained. They work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use in the operating room. Their work helps safeguard the integrity of the design and ensures that Design History Files (DHF’s) meet all regulatory requirements. The Design Controls Engineer demonstrates a strong sense of pride in their work output and a real interest in our client technology, products, and applications.
Roles & 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 for the Single Port system.
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 Intuitive Surgical’s design control processes.
Use the requirements management database tool extensively to manage design control documents, and the links between document content.
Assist subject matter experts with writing, reviewing, and/or editing documents required by Intuitive Surgical’s 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 PTC Integrity and/or 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:
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
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)
Experience with EU MDR implementation
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: