Principal R&D Process Development Engineer

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:

R&D Product Development

Job Sub Function:

R&D Mechanical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Principal Process R&D Engineer.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Principle Duties and Responsibilities may include:

• Conceptualize and lead early-stage design & process development projects of novel hemodynamic support devices and accessories.

• Conceptualize and lead initiatives with engineers in research, product development, new product introduction and contract manufacturers or OEMs.  Collaborate to deliver designs with margin to performance requirements and demonstrated process capability in scalable manufacturing processes.

• Conceptualize manufacturing methods, identify and install equipment, identify critical process inputs and outputs, develop processing windows and output specifications.

• Serve as Subject Matter Expert (SME) across platforms and lifecycle phases from research through sustaining teams.

• Collaborate and be the primary point of contact with NPI process engineering to transfer design and processes into the production environment

• Develop and train advanced technicians and operators on new processes, and updates to existing processes.

• Generate intellectual property through invention disclosures in pursuit of patients and trade secrets.

• Turn concepts into reality by rapidly prototyping using a variety of fabrication techniques.

• Test and iterate on your designs to develop an optimal solution.

• Bring solutions to market by collaborating with an exceptional cross-functional team.

• Conceptualize, design, prototype, procure, and build components and assemblies for products and testing/manufacturing fixtures.

• Conduct feasibility testing, analyze, and report on test results providing conclusions and recommendations.

• Lead and perform failure investigations in the event of test failures with support from the technical team.

• Conduct voice of the customer and transform clinical observations into new device concepts and requirements

Job Qualifications:

• BS in Mechanical Engineering or directly related scientific discipline.

• 6+ years of related experience in medical device with 3+ years in manufacturing or new product introduction.

• Strong problem-solving skills and demonstrated experience identifying root cause of device failures.

• Demonstrated ability to execute tasks in a timely manner under minimal supervision.

• Willingness to learn the interventional cardiology space - the devices and the clinical practice.

• Experience applying statistical techniques and analysis.

• Willingness & ability to travel internationally ~5% of the time. 

Strongly Preferred Qualifications: 

• Experience in FDA Class II and III medical devices preferred.

• Experie