Design Quality Engineer Co-Op

Johnson & Johnson Innovative Medicine • Raritan, NJ

3d • $23 - $52

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 Job Function: Career Programs Job Sub Function: Non-LDP Intern/Co-Op Job Category: Career Program All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: JOB SUMMARY The Design Quality Engineer Co-Op shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for the support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) Platform. WCH is a market leader in surgical tissue healing with a broad portfolio including Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies. DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Learns the details of medical device risk management and perform Application & Design Failure Mode and Effect Analysis for existing and new products. Furthermore, also contribute towards the improvement of the combination products program in compliance with 21CFR part 4 (FDA Regulation for combination products). Assists in various lifecycle management activities including product design changes, complaint trending and analysis, assessment of quality signals, CAPA and remediation activities, and integration of regulations, such as the EU MDR, into the business. Supports the Franchise Technical training program and work to expand it to manufacturing sites. This involves ensuring a robust pipeline of training offerings, managing schedules across time zones, distributing training materials, maintaining digital communications channels, and supporting the Subject Experts with developing content and facilitating their training sessions. Helps plan and execute team building events. Responsible for communicating business related issues or opportunities to next management level. Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed. EXPERIENCE AND EDUCATION Required: Enrolled in an accredited college/university Preferred majors include: Engineering, Life Science, Physical Science, or a related field. Completion of at least freshman year of undergraduate academic program. Availability to work 40 hours/week. Preferred Prior experience in Medical devices or other regulated industries. Demonstrated leadership and/or participation in campus extracurricular and community service activities. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS Begin understanding and application of core GMP fundamentals, including but not limited to Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs). The Quality Engineer Co-op is expected to begin the accumulation of the following technical quality areas: Design Control Risk Management Applied Statistics Good Documentation Practices Good Manufacturing Practices Verbal and written communication skills Detail oriented, highly organized, and able to manage multiple tasks Ability to work individually and on a team Project management, problem solving, and presentation skills Proficiency in Microsoft Office, Word, PowerPoint, Sharepoint, and Excel Proficiency in statistical analysis and statistical / visual analysis tools such as Minitab and Tableau preferred Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $23.00/hr to $51.50/hr Additional Description for Pay Transparency: The expected pay range for this position is between $23.00 per hour and $51.50 per hour but will be based on candidate's program year, discipline, degree and/or experience. Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension). For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on 12/18/2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. 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/. 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Requirements

• Enrolled in an accredited college/university
• Preferred majors include: Engineering, Life Science, Physical Science, or a related field.
• Completion of at least freshman year of undergraduate academic program.
• Availability to work 40 hours/week.
• Begin understanding and application of core GMP fundamentals, including but not limited to Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• The Quality Engineer Co-op is expected to begin the accumulation of the following technical quality areas: Design Control Risk Management Applied Statistics Good Documentation Practices Good Manufacturing Practices
• Verbal and written communication skills
• Detail oriented, highly organized, and able to manage multiple tasks
• Ability to work individually and on a team
• Project management, problem solving, and presentation skills
• Proficiency in Microsoft Office, Word, PowerPoint, Sharepoint, and Excel
• Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.

Nice To Haves

• Prior experience in Medical devices or other regulated industries.
• Demonstrated leadership and/or participation in campus extracurricular and community service activities.
• Proficiency in statistical analysis and statistical / visual analysis tools such as Minitab and Tableau preferred

Responsibilities

• Learns the details of medical device risk management and perform Application & Design Failure Mode and Effect Analysis for existing and new products. Furthermore, also contribute towards the improvement of the combination products program in compliance with 21CFR part 4 (FDA Regulation for combination products).
• Assists in various lifecycle management activities including product design changes, complaint trending and analysis, assessment of quality signals, CAPA and remediation activities, and integration of regulations, such as the EU MDR, into the business.
• Supports the Franchise Technical training program and work to expand it to manufacturing sites. This involves ensuring a robust pipeline of training offerings, managing schedules across time zones, distributing training materials, maintaining digital communications channels, and supporting the Subject Experts with developing content and facilitating their training sessions.
• Helps plan and execute team building events.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Benefits

• Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.
• Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year.
• Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).

What This Job Offers

• Career Level: Intern
• Education Level: No Education Listed