Senior R&D Mechanical 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development

Job Sub Function:

R&D Mechanical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Boston, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Senior R&D Mechanical Engineer to join our Orthopaedics team. This is a hybrid position that will be based in Boston, MA.

Key Responsibilities:

• Design and develop technology and supporting instruments for robotic applications
• Use technical curiosity for the engineering and development of robotics systems and medical devices
• Lead internal and external partnership R&D projects
• Operate with latitude contributing to or leading multi-disciplined core teams
• Create and monitor technical aspects of multiple workstreams and projects
• Understand and utilize design controls for all technical aspects of product development including the development of design inputs and outputs and the verification and validation of medical devices including software
• Analyze and evaluate new technologies and develop improvements to existing products
• Demonstrate strong proficiency in the application of design controls and development processes
• Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and ISO 14971.
• Support design transfer and product launch activities, including complaint investigations.
• Investigate and document nonconformances, deviations, and test failures; drive root cause analysis and corrective actions.
• Interface with Regulatory, Quality, and Manufacturing teams to support audits and inspections.
• Support post-market surveillance activities by providing technical analysis, product documentation, and investigation support.
• Assist with handling obsolescence and technology upgrades.
• Communicate business-related issues or opportunities to the next management level.
• Follow all Company guidelines related to Health, Safety, and Environmental practices, as applicable.
• Train, develop, and evaluate more junior engineers, contractors, engineering Co-Op students and interns
• Perform other duties as assigned.

Required Qualifications:

• Bachelor’s degree in Engineering (mechanical, biomedical, electrical, or related) or equivalent technical degree.
• 4+ years medical device experience or 6+ years’ experience in a regulated industry
• Highly effective oral and written communication skills (with strong interpersonal and critical-thinking skills), including the ability to work with all levels of the organization.
• Ability to apply technical theoretical principles to product design.
• Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T.
• Ability to effectively communicate critical design/project information to internal and external customers.

Preferred Qualifications

• Experience with Class I or II orthopaedic medical devices.
• Experience with optical tracking and digital imaging.
• Relevant experience with capital equipment, medical device materials, and plastic injection molding.
• Familiarity with embedded systems, firmware/software testing, or electromechanical systems.
• Strong understanding of systems engineering principles and the product development lifecycle, including waterfall, and Agile methodologies.
• Experience with product lifecycle management tools such as Windchill, Polarion.

About Orthopaedics:

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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

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

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