- Launch and stabilize new products through concept, design, development, and steady-state processes.
- Ensures compliance with GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), and all other applicable standards.
- Review and approve design control, manufacturing, quality, engineering, and validation/qualification documents to ensure conformance to business practices and departmental procedures.
- Drive the development of product requirements, verification strategies, and validation strategies.
- Support the Risk Management Process per ISO 14971 by constructing/maintaining a Risk Management file to include design, process, and use FMEAs.
- Develop a reliability strategy and lead reliability testing during new product development.
- Develop inspection and sampling plans for components and finished products.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.). Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
- Proactively engage partners to ensure alignment and resolve issues in a timely manner.
- Technical problem solving, failure analysis, and root cause investigation/determination.
- A Bachelor's degree or equivalent in engineering or related scientific field required.
- A minimum of 6 years of Quality, Manufacturing, or Research & Development experience in a Medical Device or other regulated industry. New Product Development experience, preferred.
- Sophisticated knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of growing complexity.
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user/patient harms.
- Successfully able to collaborate, connect and communicate with internal and external partners as a member of a team.
- Knowledge of Design for Reliability (DFR), defining reliability requirements and specifications, and development of reliability plans.
- Experience with Minitab, Reliasoft, or other statistical software.
- Medical electrical-mechanical systems experience.
- FPGA logic (VHDL, Verilog) and architectures experience.
- Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of medical devices.
- Experience leading and/or supporting audits and regulatory discussions.
- ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean).
- 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:
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Staff Quality Engineer, New Product Development - Santa Clara, United States - J&J Family of Companies
Description
Staff Quality Engineer, New Product Development W
Description
J&J MedTech is recruiting for a Staff Quality Engineer, New Product Development , located in Cincinnati, OH or Santa Clara, CA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at .
In this role you will be responsible for providing quality engineering support and leadership for New Product Development
This role supports product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Working closely with multi-functional teams, this individual will act as a domain authority for product quality throughout the development lifecycle. The individual reviews and assesses development activities (e.g., user needs, development/quality plans, requirements, architecture and design, verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits.
Key Responsibilities:
Qualifications
Education:
Experience and Skills:
Required:
Preferred:
Other:
This position may require up to 25% domestic and international travel.
The anticipated base pay range for the Santa Clara, CA location of this position is $105,000 to $166,635.
– 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 year
For additional general information on Company benefits, please go to:
This job posting is anticipated to close on May 23, 2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
Johnson & 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 ) .
Primary Location NA-US-Ohio-Cincinnati
Other Locations NA-US-California-Santa Clara
Organization Ethicon Endo Surgery Inc (6041)
Travel Yes, 25 % of the Time
Job Function Quality Engineering
Req ID: W
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