Jobs for People with MS: National MS Society

NPI Manufacturing Engineer - 2406194630W

Description

The Robotic And Digital solutions group, part of Johnson & Johnson MedTech, is recruiting for a Manufacturing Engineer NPI, located in Santa Clara, CA.

The NPI Manufacturing Engineer is responsible for acting as a team member on process development projects conducting various assignments in collaboration with direction of team & team leader. Scope of responsibility includes specifying, procuring, qualifying, validating, troubleshooting, and maintaining equipment and process needed for robotic assembly, dispensing, and/or packaging components and/or products, as well as developing components and assemblies for processing. Supports investigations to determine root cause of failures, presents results, and proposes corrective and preventative actions as required. Uses capabilities, such as Lean/Six Sigma, DFx, SPC, etc, to improve company knowledge, products and processes. Collaborates and interacts with other company engineering teams, including teams representing R&D, Product Quality, Regulatory, and Supplier Quality. Provides engineering, risk assessment, and statistics support in the development and maintenance of the company’s quality systems. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485).

Responsibilities:

• Works under general supervision.

• Develop components and assemblies using DFx, GD&T, etc.

• Develop process windows/limits for manual and automated production processes.

• Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports.

• Act as technical liaison between R&D Engineering and Manufacturing.

• Complete engineering assignments involving design, development, and testing.

• Learns and maintains methods for inspecting, testing and evaluating complaint-related product.

• Design, develop, and improve manufacturing processes, equipment, and tooling.

• Understands and applies test methods to locate, reproduce, identify, and analyze complex failures. Develop Process Failure Mode and Effects Analyses.

• Apply comprehensive & diverse knowledge of engineering principles to assignments.

• Co-ordinate activities with internal & external customers and suppliers.

• Authors and reviews technical protocols, reports, standards and change orders.

• Participates in presentation of progress and results to all levels of organization.

• Generates monthly status reports on individual activity.

Qualifications

• Basic Qualifications

• A minimum of a Bachelor of Science Degree in a technical field (for example, Electrical Engineering, Mathematics, Statistics, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, etc.) is required.

• A minimum of 4-8 years of experience in a technical field is preferred.

• Experience with CAD, Geometric Dimensioning & Tolerancing (GD&T), board design is preferred

• Experience with Process Validation (IQ/OQ/PQ), able to generate protocols and test reports

• Knowledge of LEAN/Six Sigma and Process Six Sigma is preferred.

• Understanding of Statistical Analysis used to identify issues in post-market surveillance, complaints, and servicing is preferred.

• Understanding of Risk Management (Medical Device) is preferred.

• Strong integration skills to identify Manufacturing and Supplier related issues of Medical Device Capital Equipment is preferred.

• Proven ability to work optimally with multi-functional teams for qualifications, verifications, validations, complaint investigation, root cause analysis, identification and implementation of CAPAs is preferred.

• Ability to multi-task with an established track record of meeting milestone schedules is preferred.

• Understands Failure Modes and Effects Analysis and Fault Tree Analysis is preferred.

• Prior experience or training in Manufacturing Engineering is preferred.

• Experience working in an ISO13485, GMP, or FDA regulated environment is desirable.

• Excellent interpersonal skills, both verbal and written, and the ability to effectively interface within a multi-functional team. Other:

• The anticipated base pay range for this position is $83,800 to $117,300.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)). 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

• Work, Personal and Family Time - up to 40 hours per calendar yearAdditional information can be found through the link below.

• https://www.careers.jnj.com/employee-benefitsJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location NA-US-California-Santa Clara

Organization Auris Health, Inc. (6267)

Job Function Manufacturing Engineering

Req ID: 2406194630W