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. 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.
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.
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
Compensation
The anticipated base pay range for this position is $94,000.00 - $151,800.00.
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 period
•Volunteer Leave – 32 hours per calendar year
•Military Spouse Time-Off – 80 hours per calendar year
