Amick Brown is seeking an experiencedProduct Verification Specialist: Documentationfor our direct client. Location:Sunnyvale, CA Duration: 12 Months.
The New Product Verification Department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations.
The department plays a vital role in product and process quality, in new and sustaining product development and in the quality of da Vinci Surgical System & Ion robotics system product lines.
The product verification specialist with design control guidance from Test engineers update and generate documentation that support traceability of test cases to requirements and/or specifications.
They will support the New Product Verification team on technical documentation and tracing to satisfy regulatory submission requirements.
The ideal candidate will have both the technical aptitude to understand product design requirements/ risks as well as technical documentation experience in a medical device or an equivalent regulated industry.
Roles & Responsibilities
Plays a vital role in supporting the product verification activities at our clients.
Supports new product verification team to produce high quality, consistent verification documents that meet our clients design control processes
Participates in the development, execution, maintenance, and support of product verification documents.
Additionally, the ideal candidate will have the ability to deliver technical documentation to satisfy regulatory submission requirements.
Focuses on delivering technical documentation, delivers project deliverables with minimum impact to resources and with operational effectiveness.
Assists test engineers with compiling and generating verification documents which includes test plans/protocols, reports, document tracing, general technical writing and documentation
Utilizes design controls guidance provided by test engineers to map test case acceptance criteria to functional requirements for products developed at our clients.
Uses Design control tools like PTC Integrity and/or Siemens Polarion to accomplish the following:
Update test protocols
Link test cases to functional requirements
Generate trace reports. Identify and inform testing gaps.
Reviews test reports and associated data sheets for Good Documentation Practices and supports with test report check list.
Routes documents through change management system for cross functional approvals.
Collaborates effectively with Test engineering, Test Lab, Quality, Regulatory, Project Management, Design and Document Control.
Ensures successful, on-time completion of department projects; communicates constraints to direct management when successful project completion is at risk
Performs a broad variety of tasks in support of product verification and test process design as assigned by department management
Complies with company Department and Standard Operating Procedures
Education and/or Experience: Bachelor’s Degree preferred, with strong preference for degree in engineering or equivalent technical discipline.
Experience in a medical device and/or other regulated industry with technical documentation experience is required.
Skilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat
Communication: Requires excellent verbal and written communication skills.
Must have good attention to detail.
Ability to effectively present information in one-on-one and small group situations to other employees, supervisor, or engineers.
Reasoning Ability: Must be a quick learner with ability to understand complex technical information and translate into writing.
Ability to apply commonsense understanding to carry out instructions.
Proven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction.
Other skills and abilities: Ability to work in a team environment.
Self-motivated and proactively reaches out to stakeholder to make efficient progress on projects
Ability to manage challenging assignments and effectively multitask, handle tasks with competing priorities. multiple assignments in parallel.
Ability to work independently and with minimal supervision. Assertive, outgoing personality with an ability to work collaboratively within an engineering team
Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
Travel: No Travel
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: