Senior Manufacturing Engineer

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R • Santa Clarita, CA

3h • Onsite

About The Position

The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to support product development and production efforts for all aspects of implantable medical devices and systems; research, plans and designs for mechanical and electromechanical products and systems; coordinates activities involved in fabrication, operation, application, installation, and repair of same.

Requirements

• Bachelor's degree (B.S.) from four-year college or university and 10+ years related experience; or equivalent combination of education and experience. Engineering experience in medical device (or highly regulated industry) design and/or manufacturing is preferred.
• Good understanding of CFR 820 and ISO 13485:2016

Responsibilities

• Confers with planning and design staff concerning product design and tooling to ensure efficient production methods.
• Specifies, designs, analyzes, simulates, prototypes, builds, tests, documents and releases to manufacturing parts, processes, procedures, assemblies, materials, tooling/fixtures and equipment.
• Organizes, plans, tracks, and closes out design and process issues associated with product performance in development, test, manufacturing, and the field.
• Designs and documents processes and/or tooling/fixtures and equipment such as mechanical/electromechanical, thermal, or hydraulic systems using SolidWorks or other similar programs.
• Supports build plans: enable teams and technicians to meet expectations, execute work orders, track and communicate status, provide updates and solve issues proactively.
• Works closely with teams of engineers and technicians in OPS, R&D, Quality to deliver on projects. Often coordinates tasks, technicians and will be responsible for builds and delivering portions of the entire product lifecycle from early phase prototype, characterization, verification and validation and production. Including process transfers to remote sites.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level