Johnson & Johnson is looking to solve the problem of complex calcified cardiovascular disease by developing the next generation of smarter, less invasive, and more personalized treatments through its Shockwave Medical portfolio.
Requirements
- BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience
- Experience in the medical device industry is highly preferred
- Strong technical writing and verbal skills are required
- Experience in customer complaint investigations and complaint report writing
- Experience in contract manufacturing support as a Quality Engineer
- Proficiency in MS Word, Excel and Power Point required
- Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications would be a great asset
Responsibilities
- Work with contract manufacturers to maintain product quality and resolve any non-conformances
- Prepares documentation for inspection/testing procedures, development studies, verification/validation protocols and reports, quality plans, product defect investigations and inspection plans.
- Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence.
- Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
- Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
- Independently performs most assignments with an understanding of the overall expectations.
- Responsible for participating in design reviews and product transition to contract manufacturers/suppliers, and ensure the activities meet external regulations, industry standards, and internal procedures.
Other
- Must be proactive, self-motivated, and work independently with minimal supervision
- Ability to lead cross-functional teams in problem solving and risk analysis activities
- Effective communication skills with all levels of management and organizations
- High attention to detail and accuracy is required
- Must be willing to do some minimal travel
