Vacancy expired!
Position Title: V and V Scientist – LC/MSLocation: San Jose, CA – mostly onsite. Some flexibility on hybrid down the road as they move more into documentation phase, but all onsite up front. NATIONALS OK but must relocateLength of Contract: 12 months+ Possible extensionProcess: 2 rounds - first round phone screen for 30-45 minutes with hiring manager. Second round will be onsite for 1.5 to 2 hours with 2 or 3 team leads, might involved the Product Manager if possible. Scope: Urgency is borne of client trying to launch some of their local product lines (medical devices) in Europe. They have several legacy product lines that have been FDA approved and they are expanding to make a dent in the European market, and as such they need extra sets of hands to help ensure everything is compliant with IVDR rules and regulations. Will be taking existing products and revamping with some additional features and documentation and testing to ensure everything is up to code in regulated environment. Big push from executive leadership to expand their medical device base and customer demand overseas. Roles will involve a lot of hands-on, device level testing, setting up the equipment and devices, and the documentation that goes along with it. From the JD:“We are looking to add a Validation Scientist to our team to support our growing medical device product portfolio. The incumbent will support the hardware testing and validation, particularly focused on LC/MS applications using the triple quadrupole-based instruments. The position will require to work with other V&V Scientists in the team, interact with various groups within the company, including Research and Development, Product Management, Vertical Marketing, commercial teams, as well as global demo centers.”Duties/Responsibilities:
- Operate within the Product Development Process and be familiar with the principles of working within a Quality Management System or regulated laboratories.
- Write documentation, such as test protocols, and reports.
- Maintains a laboratory notebook (and electronic documents) that records all aspects of experimental design and results, following good documentation practices, always.
- Independently perform experiments and generate data in support of product requirements.
- Responsible for accuracy and completeness of auditable documents.
- Collaborate with other scientists, engineers, and other cross-functional team members to support the development, transfer, submission, and commercialization of IVDR products.
- MS degree and 3+ years; BS and 5+ years in Chemistry or relevant field.
- 3+ years work experience with hands-on experience operating and maintaining LC and MS instrumentation.
- Experience in one or more of Proteomics, Lipidomics, Pharma/Biopharma, Clinical or Food & Environmental analytical industries.
- Experience with IVD products and working under design control.
- Demonstrated ability for high-quality results, technical proficiency, laboratory skills.
- Ability to present and communicate (oral and written) information in a clear manner.
- Self-motivated and ability to work-independently with minimal direction
- Computer skills such as Word, Excel and PowerPoint.
Vacancy expired!