MedTech Senior Project Engineer

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

Supply Chain Engineering

Project Engineering

Scientific/Technology

Leeds, West Yorkshire, United Kingdom

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we\'re developing the next 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

We are searching for the best talent for MedTech Senior Project Engineer.

As a Senior Project Engineer in the MedTech industry, you will play a key role in leading and handling the engineering aspects of innovative medical device development and manufacturing projects. You will collaborate closely with multi-functional teams, quality, regulatory, and manufacturing, to ensure timely and successful project delivery while adhering to strict regulatory standards and industry best practices.

This role requires a proven background in engineering principles, excellent project management skills, and a detailed understanding of FDA, BSI, and other regulatory requirements pertinent to medical devices.

• Lead equipment design, validation, and process improvement projects to enhance manufacturing efficiency and compliance.
• Ensure adherence to all compliance, EHS, and safety policies and guidelines.
• Collaborate with vendors to procure equipment, ensuring conformance to regulatory and quality standards.
• Perform and document installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
• Create production documentation and contribute to the development of new product BOMs and routings.
• Support regulatory submissions, including technical writing, data analysis, and trend tracking for PMA submissions.
• Develop and manage project budgets, providing input on financial planning and controlling project costs.
• Identify and implement cost reduction opportunities for future products and processes.
• Support resolution of NCRs, CAPAs, audit observations, and safety or ergonomics-related actions.
• Assist in critical engineering tasks across departments as needed.
• Utilize project management methodologies to deliver projects on time, within scope, and budget.

Qualifications / Requirements:

• Equipment and Process Validation / Establish Equipment requirements (Capital request, URS, FAT etc.)
• Project management
• Project budget management
• Team management and project and resource prioritization
• Lean and/or Six Sigma belt
• Continuous improvement

Education:

• Bachelors Degree, Engineering degree or Equivalent
• +4 years related experience

For more than 130 years, Equity & inclusion have been part of our cultural fabric at Johnson & Johnson. Our commitment to respect the dignity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. We are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.