Engineer, Biomechanical Engineering

Biopharma Asia; Chester (Delaware County); On-site; USD 80,000 - 120,000; Full time

Job summary

Johnson & Johnson's Orthopaedics division seeks an Engineer, Biomechanical Engineering to lead design and development of implants and instrumentation. You will work in West Chester, PA, guiding projects through product life-cycle, collaborating with marketing, manufacturing, quality, and regulatory teams to ensure clinical and regulatory compliance.

You will apply CAD techniques, GD&T, FEA, and rapid prototyping to deliver robust solutions, while supporting MDR, 510(k) submissions, and

Qualifications

• Experience with CAD design and engineering analysis.
• Knowledge of GD&T and tolerance studies.
• Familiarity with design verification/validation activities.

Responsibilities

• Lead design and development activities across the product life cycle.
• Coordinate with cross-functional teams (marketing, manufacturing, quality, regulatory).
• Engage health care professionals to define user needs and design inputs.
• Develop verification/validation plans and protocols for regulatory submissions.

Skills

CAD design

FEA

GD&T

Prototyping

Tools

CAD software

FEA tools

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:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

West Chester, Pennsylvania, United States of America

Job Description:

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

DePuy Synthes is recruiting for a Engineer, Biomechanical Engineering to be basedin West Chester, PA

Purpose:

Helps lead the design and development of new implants and instrumentation and/or support in-market products through their product life-cycle within a cross-functional project team. This includes communication with customers, e.g., Health Care Professionals and marketing, understanding of clinical issues, defining the design parameters, and ensuring the product which is provided to the customer meets functional requirements.

Job Responsibilities:

The R&D Engineer 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.

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.

Knowledge of existing product lines and detailed knowledge of applicable anatomic injuries/pathologies as well as treatment options

Understands and follows the New Product Development process accurately.

Perform complaint investigations and field investigation activities in support of patient/customer safety.

Support/Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.

Will be responsible for initial patent review of designs for freedom to operate.

Support Operations projects associated with Cost Improvement Projects and Production Transfers.

Performs other special projects and functions as assigned.

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.

Diligently participate