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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Employer: Biosense Webster, Inc.

Job Title: Staff Quality Engineer, Product Development

Job Code: A011.3480

Job Location: Irvine, CA

Job Type: Full-Time

Rate of Pay: $140,000 - $165,000

Job Duties: As part of New Product Development team, contribute to development activities, including design verification test, process validations, and quality processes. Serve as subject matter expert on quality lifecycle management and related Quality tools. Responsible for revision/approval of engineering drawings for both device components and Tool/Jig/equipment, correct application of GD&T, stack up analysis, etc. Develop and establish effective quality control and associated risk management plans. Support all Quality Engineering activities for the Life Cycle Management function, including Cost Improvement Projects (CIPs) and Component Qualification activities. Ensure compliance with the internal quality system policies and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other standards as applicable to medical devices. Contribute to quality and process activities for Reliability, Risk Management, Analytics/statistical techniques, Requirements Management, and Verification & Validation. Lead quality improvement efforts for legacy products, continuous improvement, and customer satisfaction. Design or redesign mechanical and thermal devices or subsystems, using computer-aided design, and develop and test prototypes. Write, review, and/or approve process and product validation protocols and reports, equipment qualifications, and engineering change orders. Use statistical tools to analyze data, make acceptance decisions, and improve process capability, with Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc. Direct Failure Mode and Effects Analysis (FMEA) activities for both Design and Process risk assessments. Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products. Investigate equipment failures or difficulties to diagnose faulty operation and to recommend remedies. Participate in Material Review Board (MRB) review of nonconforming product, and recommend disposition and corrective action.

Requirements:

Employer will accept a Master's degree in Mechanical Engineering, Manufacturing Engineering, or related field and 3 years of experience in the job offered or in a Staff Quality Engineer, Product Development-related occupation.

This job posting is anticipated to close on 4/2/2025.

The anticipated base pay range for this position is:

$140,000 - $165,000

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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