Manager, Process Engineering - Orange County, CA.

Engineering Manager in Orange County, CA

Posted 2019-10-08

Job Summary
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
Minimum Qualifications
 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;
Preferred Qualifications
 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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