Senior Development Quality Engineer
About The Position
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 https://www.jnj.com/. 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 regulatory requirements, 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.
Requirements
- A Bachelor’s degree or equivalent in engineering or related scientific field required.
- A minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry required, 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
Nice To Haves
- Medical electrical-mechanical systems experience.
- Knowledge of FDA requirements for design control 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).
- Knowledgeable in SolidWorks, other CAD based programs (basic dimensioning, tolerance stack analysis).
- Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.
- Experience working with external manufacturers and suppliers
Responsibilities
- 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 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.
- 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 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.
Benefits
- employees are 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.
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
