Manufacturing Engineer II
About the Company
Our purpose at Talis Biomedical is to advance health equity and outcomes by delivering accurate infectious disease testing in the moment of need, at the point of care.
While timely diagnosis of infectious diseases is critically important to enable effective treatment, testing is primarily performed in centralized laboratories, which require samples to be shipped for processing, delaying the return of results by days.
Point-of-care testing solves this problem by delivering the timely information necessary for clinical care.
To deliver our purpose we focus on three things :
- Putting customers and patients first
- Making Talis a great place to work
- Living our values to Dream Big, Share Our Screens, Serve Others, Bring Our A Game, and Build Trust
Job Title : Manufacturing Engineer II Division / Department : Operations Manufacturing Engineering Reports to : Senior Manager of Manufacturing Engineering Date : May 2023 Position Summary This position will report to a Sr.
Manager Manufacturing Engineer and will be responsible for developing, documenting, and validating manufacturing processes for an IVD Consumable.
Specific responsibilities include, but are not limited to :
- Develop and control efficient manufacturing processes for assembly of a microfluidic cartridge containing injection molded components, wet and dry reagents, and a wide range of assembly processes.
- Own and maintain design and process documentation including Item Specification, Process Instructions, BOM, Drawings, etc.
Perform change management, including creation and routing of change orders, identifying appropriate process impacts, risks, and justification for change.
- Assist in identifying and procuring manufacturing equipment ranging from custom large-scale PLC / PC -based automation equipment to small fixturing.
- Own, plan and execute design transfer activities, including validation of equipment and processes, requirements creation, Master Validation Plans, IQ / OQ / PQ Protocols and Reports, Test Method Validation, Process Flow Diagrams, pFMEA, etc.
- Transfer manufacturing processes to internal and external suppliers, collaborating effectively across functions to meet various customer needs, including appropriate training.
- Lead cost reduction, capacity scaling, and quality improvement activities (equipment and manpower) to meet business needs.
- Participate in CAPA investigations, NCM resolution, failure and root-cause analysis, and other investigation activities.
- Ensure compliance to Quality System Requirements within an FDA regulated manufacturing environment.
- Leverage a strong understanding of manufacturing metrics to appropriately select process indicators that quickly and effectively communicate product and process health.
- May be asked to support pilot manufacturing on automation system, or other tasks as required by the company.
- Mentor junior engineers.
Education / Skills / Requirements
- BS / MS degree in Mechanical Engineering or equivalent.
- 3 - 5 years of experience in FDA regulated product development or manufacturing desired.
- Excellent communication, organization, follow-up, and documentation skills.
- Strong problem-solving skills.
- CAD experience (Solidworks preferred).
Talis Biomedical offers a comprehensive health and well-being benefits programs, long-term equity incentives, time-off policies, a 401(k) retirement savings plan with an immediate Company match, Education Assistance Program, a rotating suite of snacks, Happy Hours, office perks, and other fun company events! Best of all, join us by working at a growing company like Talis with dedicated and collaborative employees committed to making a difference in Health Care.
Talis Biomedical is proud to be an equal opportunity workplace. All aspects of employment decisions will be based on merit, competence, performance, and business needs.
We do not discriminate on the basis of any status protected under federal, state, or local law. We celebrate diversity and are committed to creating an inclusive environment for our colleagues.
Talis Biomedical is an E-Verify Participation company.