Amick Brown is seeking an experienced Senior Validation Engineer
for our direct client.
: Sunnyvale, CA
: 1 Year
Roles and Responsibilities
- Provide design input early in the development process for cleaning and sterilization approaches, validation of reusable products, instructions for use, as well as, to support ongoing product design enhancements and field issues.
- Needs to have a good working knowledge of domestic and international standards related to reprocessing.
- Act as the primary interface for cross-functional teams supporting development of new instruments, accessories and endoscopes, as well as, external laboratories.
- Provide cross-functional teams with appropriate design inputs for cleaning, disinfection and sterilization for ISI reusable devices and conduct validations to support 510(k) submissions.
- Interaction with final users to understand central reprocessing processes, help streamline workflows and improve instructions for use.
- Excel in a high-energy, high capacity, working in a fast pace environment with multidisciplinary teams to drive to solutions from early design requirements to product launch and support.
- Ability to learn rapidly, create innovative solutions and high commitment to product quality are essential.
- A strong sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting.
- Lead multiple validation and verification studies including cleaning, disinfection and sterilization involving rigorous data analysis with focus on the safety and efficacy of new da Vinci surgical medical devices.
- Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and outside services (vendors and laboratories).
- Define reprocessing test approach and test plans to ensure safety and efficacy for new instrument and accessory products across the company’s product platforms. Provide subject matter expert input for design, materials, and product requirements for optimized reprocessing output.
- Collaborate with Regulatory Affairs to support regulatory submission (510(k)) and approvals
- Develop and maintain procedures and best practices to ensure compliance with applicable US and international cleaning and sterilization standards.
- Optimize cleaning and sterilization control processes, systems, and procedures.
- Support development of harmonized reprocessing manuals for end users, minimizing reprocessing complexity and ensuring compliance with AAMI and ISO standards for medical devices.
- Good working knowledge of medical device industry, standards and guidance for medical device reprocessing.
- Support field visits to central reprocessing customer sites and make recommendations for improvements to streamline reprocessing workflows
- Participate on AAMI working groups in the development of new standards in this field
- BS in Engineering, Life Science, Microbiology or technical equivalent; Masters is preferred
- Minimum 8 years of professional experience in the medical device field, with at least 3 years in:
- Medical device cleaning validation experience
- Medical device sterilization validation experience (including steam, EO, and low- temperature modalities)
- Developing reprocessing instructions/manuals for complex medical devices
- Familiarity with US and international (OUS) medical device cleaning, disinfection, and sterilization standards such as AAMI TIR 12, TIR30, ISO 11135, ISO 11137, AAMI TIR 28.
- Superior verbal/written communication, teamwork, and interpersonal skills to work across multiple constituents.
- Self-starter with ability to lead in a fast-paced environment.
- Able to prioritize, manage multiple projects and focus execution
- Hands-on experience with proven ability to work well in cross-functional team environment and meet project goals
- Attention to detail along with flexibility to support various projects
- Well versed in MS Office Suite including statistical analysis tools.
- Ability to travel to customer or laboratory sites (10%), including international 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:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs