Amick Brown is seeking an experienced Design Validation Engineer
for our direct client.
Location: Sunnyvale, CA
Duration: 5 months
Roles and Responsibilities
- The Design Validation Engineer plays a vital role in developing safe and effective medical devices
- As an embedded member of the Digital team, they will manage/conduct software validation deliverables in support of software applications within the Digital organization.
- 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 (DHFs) meet all regulatory requirements.
- The Design Validation Engineer is expected to bring to their role a passion for proper design control methodology, a strong sense of pride in their work output, and a real interest in client’s technology, products, and application.
- Use traceability database software tools extensively to manage design control and SDLC documents and the links between document content.
- Extensive data entry and management will be required.
- Assist the Digital team with compiling and updating engineering design control documents for Design History Files, including risk analyses, requirements, tracing and design verification and validation test documentation.
- Use change control management system (Agile) to release and update controlled documents, route Engineering Change Orders, maintain Design History Files.
- As an embedded core team member, work with core team to outline all product validation and design control deliverables for projects
- Support validation projects for new applications as well as change control of existing applications.
- Train Digital organization to software validation requirements (Procedures/ Standards/ Best Practices).
- Support design team to produce high quality, consistent design documents that meet clients requirements.
- Coordinate with other departments as necessary in order to assure that product documentation (including user manuals, labeling, and training) is consistent with design documentation.
- Bachelor’s Degree in engineering, other technical area preferred. Software focus preferred.
- Excellent technical writing and communication skills
- Strong attention to detail to minimize documentation errors
- Ability to understand complex technical information and translate into writing
- In-depth understanding of design control best practices and GxP and Part 11. Knowledge of GAMP preferred.
- A minimum 5 years work experience with Design Control or CSV focus within the Medical Device and/or Pharmaceutical Industries is desirable.
- Experience writing and reviewing engineering complex technical information and translate (design control) documents, including specifications, test protocols and test reports
- Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs) and other risk management (ISO 14971)
- Ability to manage challenging assignments and multiple assignments in parallel
- Assertive, outgoing personality with an ability to work collaboratively within an engineering team
- Skilled in the use of Microsoft Office Suite
- Strong data entry skills
- Ability to multi-task and work independently with minimal supervision
- Understanding of design control (21 CFR 820.30) and SDLC concepts
- Skilled in the use of Agile (or similar lifecycle management system tool) and PTC Integrity, Polarion, DOORS, or other requirements management (ALM) tool
- Experience with ISO 13485, ISO 14971, ISO 80002, IEC 62304, 21 CFR Part 11, 21 CFR 820 and FDA GMPs.
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:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs