Manufacturing Engineering, Manager (Medical Tech)

The Manufacturing Engineering Manager is responsible for managing the development, improvement, and validation, of new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports production transfers from Masimo HQ and Operations to Malaysia manufacturing plants, implements and supports/utilizes affective manufacturing methodologies, such as Lean/Six Sigma following international regulatory standards (e.g. 21 CFR, Part 820 and ISO 13485:2003). Manages all engineering projects and resolves engineering problems. You will leverage your technical experience and skills to guide the team in the evaluation of product reliability performance and driving improvement on challenging technical problems.



Duties & Responsibilities

Effectively leads one or more workgroups with a staff of Electro-Mechanical, Automation, Industrial Engineers and Process Engineers as well as IT & IS support functions;

Responsible for driving and executing on process design, development and launch of new products

Manage the design/specification/purchase/installation of the Company’s assembly equipment and tooling;

Coordinate the day to day support to production (Customer claims, problem solving, deviations, NCR, yields, process & equipment issues…) to ensure the process is enabled to achieve the operation goals;

Coordinate the formulation and release of all pertinent Manufacturing Assembly Procedures, Acceptance Procedures, Inspection Procedures for all personnel in the Operation; May rewrite processes to improve detail, incorporate visual aids, with the intent of improving the overall quality of Masimo products;

Coordinate performance of process validations (IQ, OQ, PQ) including generating protocols and reports in accordance with 21 CFR Part 820 FDA guidelines;

Review and approve protocol and written reports.

Provides guidance and/or approval of workgroup technical approaches, products and processes

Establish Statistical Process Controls for Manufacturing Operations;

Coordinate development of Process Failure Mode and Effects Analyses (PFMEA);

Coordinate development and implement lean manufacturing processes to build new products and improve existing processes;

Oversee initial product builds (engineering units, pilot units, process validation units) and coordinate a smooth transfer of new products into production;

Develop manufacturing plans, project timelines, requirements, specifications and process flow;

Work closely with design engineering to proactively influence designs for better manufacturability;

Must be able to travel domestically and internationally;

Perform special projects as requested