The Manager, Process Engineering 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 to international Masimo manufacturing plants, implements and supports/utilizes effective
manufacturing methodologies, such as Lean/Six Sigma, DFM, visual Workshop, SPC, etc., always following
domestic and international regulatory standards (e.g. 21 CFR, Part 820 and ISO 13485:2003).
Duties & Responsibilities
Effectively lead a staff of Engineers on project prioritization, process validations, and continuous improvement
Manage the design/specification/purchase/installation of the Company’s assembly equipment and tooling;
Act as liaison between R&D Engineering and Satellite manufacturing (i.e. Mexicali);
Establish Statistical Process Controls for Manufacturing Operations;
Technically support satellite manufacturing plants through affective communication
Drive continuous improvement of engineering technical capabilities
Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of
projects in progress on a regular basis.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals
which align to department plans and manages the execution of goals through coaching and mentoring.
Maintains a safe and professional work environment.
Review and approve protocol and written reports.
Continuously research, learn, and recommend best practices for world-class manufacturing
Must be able to travel domestically and internationally ;
Perform special projects as requested
10 years manufacturing/process development experience, with minimum 2 years of technical staff management
experience and 3 years of project management experience involving coordination of cross-functional teams.
Bachelor’s degree in Engineering.
Demonstrated success in leading mfg technology transfer project to global operations.
Knowledge and experience in 21 CFR, Part 820 and ISO 13485:2003 requirements.
Experience with electromechanical assembly and testing ;
Experience with statistical techniques (e.g., DOE, SPC).
Experience in process automation, verification and validation;
Excellent conceptual, analytical, and problem-solving abilities;
Excellent computer skills – Solidworks (CSWA), word processing, and spreadsheets;
Ability to be part of a team and adept in building and leading teams;
Knowledge and experience in FDA QSR requirements and preferably ISO 9000 requirements;
Good communication skills, both verbal and written, and the ability to effectively interface with Research and
Development, and Quality Assurance;
Master’s degree in Engineering.
5 years prior experience in medical device manufacturing preferred.
Experience with design, development, and validating manufacturing processes for an electro-mechanical
device containing software.
Excellent CAD (Solidworks) skills, CSWP.
Demonstrated ability to manage engineers with large scale projects and deliver results on time and within
Experience in taking a major device from inception to customer shipment.
Design experience (the ability to design for manufacturability); Basic device software knowledge.
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