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. Ethicon Endo-Surgery Inc., which was created 20 years ago, in Cincinnati, Ohio, develops innovative devices that have driven the revolutionary shift from open to minimally invasive surgery and continues to lead this industry today.

DUTIES & RESPONSIBILITIES

The Associate Quality Engineer will participate in a range of initiatives including:

• Serve as the Quality lead on multi-functional product development teams in matters relating to Quality Engineering.
• Participate in cross-functional teams towards the implementation of a combination products program in compliance with 21CFR part 4 (FDA Regulation for combination products). 
• Support design control and process validation activities for new products and change products.
• 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.
• Lead and ensure the development of comprehensive risk management plans for the product and process.
• Ensure effective and comprehensive quality strategies.
• Ensure the development and validation of appropriate test methods for design and manufacture of products and components
• Assist in thorough investigation of quality issues and effective corrective and/or preventive action.
• Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device and/or combination products regulations. 
• Identify areas of opportunity for improved customer experiences through the evaluation of available post-market customer data and trending of complaint data.   
• 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.

Required:

• A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required; A Master’s Degree is preferable
• Must be authorized to work in the United States and not require sponsorship in the future.
• MS computer skills including Power Point, Word, and Excel are required.
• A minimum cumulative G.P.A. of 3.2 (based on 4.0 scale) is required.
• Availability to work full time (40 hours/week) for 10-12 weeks in the summer of 2018 is required

Preferred

• Prior experience in Medical Device or other regulated industry is preferred
• Related experience through Co-ops, Internships, or other Industry/Academia experience is preferred
• Demonstrated leadership and/or participation in campus/community service activities are preferred
• Knowledge of statistical analysis and statistical analysis tools such as Minitab is preferred

LOCATION & TRAVEL REQUIREMENTS

• Position location: Somerville, New Jersey;
• This position may require up to 25% travel: Domestic (US) and International

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.