Manufacturing Engineering Manager

Intuitive•Sunnyvale, CA

107d•$137,200 - $232,200•Onsite

About The Position

Lead team responsible for Process Development, Design Transfer, and Production Support. Actively participate in the development and refine of assemblies, manufacturing processes, associated tooling, and test methods. Deliver the product on schedule and on budget by employing core capabilities including project management, process development, lean manufacturing, and team play. Continue to improve and support production, and delivery of quality product to the customer.

Requirements

Demonstrated Mechanical and Process Engineering ability
Demonstrated ability in failure analysis and continuous improvement
Demonstrated ability to represent the company to its partners, suppliers, and vendors
BS degree in an engineering applicable discipline.
5+ years of engineering experience in manufacturing electro-mechanical products.

Nice To Haves

MS degree in mechanical or industrial engineering
Experience in Medical Device Manufacturing (including GMP, MDD, ISO) – a plus
Experience with Lean Manufacturing and/or 6-Sigma techniques – a plus

Responsibilities

Ownership through the complete lifecycle from process development, process validation, full production ramp, sustaining, and end of life.
Drive creation of efficient manufacturing assembly line, specifying and refining assembly and test processes, workflows and detailed manufacturing instructions (MPIs).
Manage and allocate team resources over multiple projects. Negotiate for needed resources to enable project/program success.
Evaluate and present production capability, status, risks, and mitigations at product development focal reviews.
Drive team to plan and satisfy goals focused on vital few organizational needs.
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation through Agile.
Creating budget estimate for new product introduction resources, prototype materials, tooling and engineering tests.
Must possess strong written and verbal communication skills to interface with management peers, suppliers, and a host of ISI organizations including, new product development, planning, purchasing, quality, regulatory, inspection, and marketing.
Ensure the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.