The role will be responsible for the design and development aspects of a project, participating on cross-functional project teams through all phases of the product life cycle, and assisting the project leader with planning and executing projects or portions of a project through product launch, commercialization, and post market surveillance.
Key Responsibilities
Technically lead design and development projects with oversight, and will work closely with the project leader, members of the project core team (marketing, manufacturing, quality, testing, supply chain, regulatory, etc.)
Engage Health Care Professionals and other functional departments to define user needs and design inputs
Solve design problems utilizing CAD techniques, rapid and conventional prototyping, and other available technologies
Develop layouts and tolerance studies utilizing GD&T, and will participate in performing design evaluations (such as FEA, simulated use testing, dry labs and wet tissue/cadaver labs etc.)
Development and execution of design verification/validation plans, test methods and protocols, and will support regulatory processes for global registration efforts.
Performs the required activities and generate the appropriate documents to ensure compliance with MDR, FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies
Work with supply chain and manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation
Demonstrate proficiency in the application of design controls and development processes and support the project leader with aspects of the project management functions including scope definition, and contingency planning
Perform complaint investigations and field investigation activities in support of patient/customer safety
Will be responsible for initial patent review of designs for freedom to operate.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times
Responsible for communicating business-related issues or opportunities to next management level
Required Qualifications
BS in Mechanical Engineering, Biomedical Engineering, or equivalent
2-6 years of experience in the design and development of medical devices, mechanical products, or biomechanical systems
“Hands on” Engineering experience
Experience with CAD software (Pro-E, Creo, SolidWorks, etc.)
Understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T
Ability to work with wet tissues/cadaver and within an Operating Room setting
Demonstrated success in bringing products from design through introduction on time
Strong communication and interaction skills, with the ability to interface with Health Care Professionals and sales/marketing personnel
Strong problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations
Demonstrated creative design ability
Demonstrated ability to prioritize tasks and manage a varied workload
Preferred Qualifications
Master’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent
Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements
The ability to review and critically assess patents and other forms of intellectual property
Excellent technical writing and communication skills
Proficient in sample size calculation and statistical methods for analyzing data
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.
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Required Skills
Preferred Skills
Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Data Reporting, Data Savvy, Design of Experiments (DOE), Detail-Oriented, Execution Focus, Feasibility Studies, Preclinical Research, Problem Solving, Process Oriented, Prototyping, Report Writing, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy
The anticipated base pay range for this position is
$76,000.00 - $121,900.00
Additional Description for Pay Transparency
- 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
