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The Ethicon business offers a broad range of products, platforms and technologies including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Based in Somerville, New Jersey, Ethicon Inc. was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery.
Duties & Responsibilities
The Co-Op of Quality Engineer will participate in a range of initiatives within the Wound Closure business including:
Support a Quality Engineer lead on multi-functional product development teams in matters relating to Quality Engineering supporting sutures, meshes, needles, tissue skin adhesives, and combination products.
Support life cycle management activities including product design changes, updates to risk documentation, complaint trending, assessment of quality signals, remediation activities, and integration of regulations such as the EU MDR.
Partner with more senior Engineers to ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.
Support the generation of risk management plans and application & design FMEA's for existing products as part of a procedural upgrade.
Identify areas of opportunity for improved customer experiences through the evaluation of available post-market customer data and trending of complaint data.
Participate in cross-functional teams towards the enhancement of the combination products program in compliance with 21CFR part 4 (FDA Regulation for combination products).
Support the development of combination products including elements of pharmaceutical GMP's such as annual product stability, tracking of drug degradation, establishment of yield targets, supporting cleaning validations, and developing sampling plans for the inspection of reserve samples.
Be a leader for the department engagement team planning and executing monthly activities and community service projects.
Candidates must be enrolled in an accredited college/university pursuing a Bachelors or Masters degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Electrical Engineering or a related field.
Candidates must be in the second year or above in school at the start of the co-op.
Candidates must be familiar with basic statistics concepts/terminology
If not in an engineering application- other roles are acceptable (i.e. budget management from a club, or any experience working with numbers)
Candidates must be available to work Full-time.
Candidates must be legally authorized to work in the United States and not require sponsorship for employment visa status (e.g. H1-B status) now or in the future.
Candidates must be detail-oriented, highly organized and able to manage multiple tasks.
Candidates must have the ability to work individually (independently) as well as on a team.
Candidates must to be proficient with Microsoft Office (Word, Excel, Power Point) and have strong oral and written communication skills.
Candidates must have a minimum G.P.A. of 3.00.
Demonstrated leadership/participation in campus programs and/or community service activities.
Previous quality engineering related experiences.
Knowledge of FDA or regulatory guidance.
Medical related experience (previous co-op at medical device company, working volunteering at a hospital, etc.).
Advanced familiarity with statistics concepts/terminology (either from previous co-ops or classwork)
Understanding of risk management.
Failure analysis/root cause understanding.
Experience with statistics software (e.g. Minitab, Weibull/Reliasoft, SAS, etc.).
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.
Ethicon Endo Surgery Inc (6041)
Johnson & Johnson