Senior R&D Mechanical Engineer

Johnson & Johnson Innovative Medicine•Boston, MA

6d•$94,000 - $151,800•Hybrid

About The Position

Johnson & Johnson is seeking a Senior R&D Mechanical Engineer to join its Orthopaedics team in a hybrid position based in Boston, Massachusetts. The role focuses on designing and developing technology and supporting instruments for robotic applications and medical devices. The engineer will contribute to or lead multidisciplinary development teams and internal and external R&D partnerships, manage technical workstreams, and apply design controls throughout product development, including design inputs and outputs and medical-device verification and validation. The position includes evaluating new technologies and improving existing products while ensuring compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and ISO 14971. Responsibilities also include supporting design transfer, product launches, complaint investigations, nonconformance and test-failure investigations, root cause analysis and corrective actions, audits and inspections, post-market surveillance, and technology upgrades. The engineer will communicate business-related issues and opportunities, follow applicable health, safety, and environmental guidelines, and train and develop junior engineers, contractors, co-op students, and interns. The role is part of Johnson & Johnson’s Orthopaedics organization. The company has announced plans to separate the Orthopaedics business and establish DePuy Synthes as a standalone company; if the transaction is completed, the position is anticipated to become employment with DePuy Synthes under its employment processes, programs, policies, and benefit plans.

Requirements

Bachelor’s degree in engineering (mechanical, biomedical, electrical, or related) or an equivalent technical degree.
At least 4 years of medical device experience or at least 6 years of experience in a regulated industry.
Effective oral and written communication, 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 manufacturing types, mechanisms, materials, proper tolerancing, drafting standards, and GD&T.
Ability to communicate critical design and project information effectively to internal and external customers.
Strong proficiency in design controls and product development processes.

Nice To Haves

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 or 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 or Polarion.

Responsibilities

Design and develop technology and supporting instruments for robotic applications.
Apply engineering curiosity to the development of robotics systems and medical devices.
Lead internal and external partnership R&D projects.
Contribute to or lead multidisciplinary core teams.
Create and monitor technical aspects of multiple workstreams and projects.
Apply design controls to product development, including development of design inputs and outputs and medical-device verification and validation, including software.
Analyze and evaluate new technologies and develop improvements to existing products.
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.
Work with Regulatory, Quality, and Manufacturing teams to support audits and inspections.
Support post-market surveillance with technical analysis, product documentation, and investigation support.
Assist with obsolescence and technology upgrades.
Communicate business-related issues or opportunities to the next management level.
Follow applicable Company health, safety, and environmental guidelines.
Train, develop, and evaluate junior engineers, contractors, engineering co-op students, and interns.
Perform other duties as assigned.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year, with different amounts specified for employees residing in Colorado or Washington, subject to policy and date of hire.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental leave: 480 hours within one year of a child’s birth, adoption, or foster-care placement.
Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a 52-week rolling period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.