Senior R&D Mechanical Engineer

Biopharma Asia; Boston (MA); Hybrid; USD 94,000 - 152,000; Full time

Job summary

Johnson & Johnson in Boston, MA, is seeking a Senior R&D Mechanical Engineer to join the Orthopaedics team in a hybrid role based in Boston. You will design and develop robotics-enabled medical devices, lead multi-disciplinary core teams, and apply design controls throughout development to ensure regulatory compliance.

Strong communication, GD&T, and manufacturing knowledge are required, with experience in orthopaedic devices encouraged.

Qualifications

• Bachelor’s degree in Engineering (mechanical, biomedical, electrical, or related) or equivalent technical degree.
• 4+ years medical device experience or 6+ years in a regulated industry.
• Strong oral and written communication skills.
• Ability to apply technical principles to product design.
• Understanding of manufacturing, tolerancing, GD&T.

Responsibilities

• Design and develop technology and supporting instruments for robotic applications.
• Lead internal and external R&D projects across multi-disciplinary teams.
• Ensure design controls and regulatory compliance for medical devices and software.
• Support design transfer and product launch activities and investigations.
• Interface with Regulatory, Quality, and Manufacturing teams for audits and inspections.

Skills

Communication skills

GD&T understanding

Design controls

Engineering principles

Education

Bachelor’s degree in Engineering or related

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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 accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Auto-CAD Design, Business Case Modeling, Coaching, Design Thinking, Mechanical Engineering, Problem Solving, Process Oriented, Product Reliability, Project Management Methodology (PMM), Project Support, Quality Control Testing, Research and Development, Resource Allocation, SAP Product Lifecycle Management, Technical Credibility, Technologically Savvy

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

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 the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits