Senior R&D Mechanical Engineer

Johnson & Johnson•Boston, MA

5d•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 teams and internal and external R&D partnerships, with responsibility for technical workstreams and projects across product development. The position applies design controls throughout product development, including defining design inputs and outputs and verifying and validating medical devices, including software. It also supports regulatory compliance, design transfer, product launches, complaint investigations, post-market surveillance, and product lifecycle activities. The engineer works with Regulatory, Quality, and Manufacturing teams and helps train and develop junior engineers, contractors, Co-Op students, and interns.

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.
Highly effective oral and written communication skills, including strong interpersonal and critical-thinking skills and 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.

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/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 R&D partnership 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 developing design inputs and outputs and verifying and validating medical devices, 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.
Interface 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 management 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

Participation in the company’s consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year, with different amounts specified for Colorado and Washington residents.
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.