Staff Manufacturing Engineer, Fluidics Consumables

Imperative Care•Campbell, CA

11d•$150,000 - $167,000•Onsite

About The Position

This position is responsible for In-House and Contracted Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance with the company’s Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and, ultimately, scalability for commercialization for Telos’ single use fluidics consumable products. This product includes high pressure pumping and priming, and flow control through a complex fluidic and sensor driven architecture. This position may be an individual technical innovation contributor or, as needed, supervise a technical team with responsibility for mentorship and development of other manufacturing engineers, technicians, and/or operators.

Requirements

BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
Experience with fluidics systems and subsystems and their interaction and interface with capital hardware and other single use disposables is highly desired
Experience and knowledge of medical device adhesives and bonding processes across various materials is highly desired
Previous experience in medical device industry with an emphasis on single use devices and consumables highly preferred

Responsibilities

Lead and oversee the manufacturing activities and deliverables for a single use fluidics consumable product.
Manage in-house and contract manufacturing activities and relationships to ensure single use fluidics consumable products are manufactured in accordance with product plans and quality/regulatory requirements.
Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields.
Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) or Device History record (DHR’s) in collaboration with R&D and Quality.
Ensure that all single use consumable products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements.
Plan equipment and workflow layouts in manufacturing areas.
Manage manufacturing equipment design and development to ensure that equipment is cost-effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Company’s Quality System requirements