Project Engineer

Project Engineer

Location: Cork

Duration: 12 months

Hours: 39 hours

Project Engineer in the Engineering Department. The role involves utilizing project management best practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilize Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will be tasked at the design, procurement, installation, validation of assets that will be involved in the manufacturing of Knee/hip construct.

Roles and Responsibilities

• Team member representing the Engineering function supporting projects with a focus on capacity expansion, install, validation, of assets used in the manufacturing processes.

• Prepare several documents as part of the IQ, OQ, PQ processes. 

• Support colleagues to complete several tasks

• Responsible for ensuring design of machine is aligned with operations needs, quality, EHS, validation, quality automation, maintenance requirements. 

• Validate the machine as per the specifications, procedures, regulations  

• Determine operational & process inputs and outputs ranges of machine prior to commencing validation 

• Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s of assets and associated machines. 

• Develop pFMEA documentation to support processes as part of Validation process

• Partner with Quality, Operations, CSV and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.  

• Communicate effectively with project manager and other managers, global functions and internal team on status of project(s) tasks, issues and requirements.

• Provide timely and accurate reporting and management of escalations as appropriate on project activities.

• Ensure all activities comply with GMP, ISO and quality system requirements.

• Ensure that all health, safety and environmental requirements are fulfilled.

• Work with vendor to ensure design specification documents meet site requirements

• Ensure asset meets requirement specifactions as per agreed User Requirement Specifiaction (URS)

• Complete testing with vendor to ensure parts are processed correctly, effiently and meet quality requirements

• Develop training documentation and supply training to appropriate function for general asset operation, recovery methods and preventative maintenance

How to Succeed

• Technical degree in related discipline (Engineering/Science/Chemical) preferred. 

• BSc in Engineering or Science with >2 years’ experience in a medium to high volume manufacturing environment

• 3 years in a similar capacity in a regulated industry (i.e. FDA/ISO)

• A thorough understanding of GMP/ISO and validation regulations. 

• Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.

• Problem solving engineering expertise (Six Sigma, SE or A3)

• Understanding of the Mechanical Engineering process and Process Validation expertise is preferred

• Strong verbal and written communication skills 

• Knowledge of Cognex vision system for support of vision job files using insight explorer

• Knowledge of dataman scanners

• Training in robotic loading systems, preferably Fanuc and ABB

Benefits

This role offers a very competitive hourly rate. This contract will run for a 12 months.

about DePuy Synthes

DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS™ Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes. 

https://www.jnjmedtech.com/en-US/companies/depuy-synthes

https://www.jnjmedtech.com/en-GB/companies/depuy-synthes

Application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity 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. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.