Sr Engineer II, Process

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, 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 Electro-Mechanical, Automation and Industrial Engineers;
• 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 Production Operations through affective communication ;
• Drive continuous improvement of engineering technical capabilities;
• Prepare and present technical reports, analysis, recommendations on the status and results of projects on a regular basis to senior management;
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback;
• Ensures workgroup products or processes meet customer, company, quality, industry and regulatory requirements;
• 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, upto 20% to visit Masimo facilities and vendors;
• Perform special projects as requested.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 8 years manufacturing/process development experience, with minimum of 2 years' experience leading projects and 3 years of project management experience involving coordination of cross-functional teams
• 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
• Basic device software knowledgeExperience 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
• 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 budget
• Experience in taking a major device from inception to customer shipment
• Experience with plastic injection molding
• Experience with cable assembly processes including cable preparation, hand soldering, crimping etc.
• Design experience (the ability to design for manufacturability)
• Basic test and device software knowledge

Education

Bachelor's degree, preferably in Engineering or related field is required.

Compensation: The anticipated range for this position is $130,000 - $175,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.