Senior Project Engineer - Cork

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Project Engineer to join our contingent workforce on a growing team at Depuy Synthes Cork. This will be an initial 12 month contract.

About DePuy Synthes: 

DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative, and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services, and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.   

The Role: 

You will join the join the team as a technical lead. You will be a key member of an NPI Engineering project team at the Cork Innovation Centre, to develop, qualify & launch a manufacturing process capable of repeatedly making new products to safety, quality, service and cost standards.

Key Responsibilities:

• Planning and execution of verification and validation activities, including:
• Generation of Validation Protocols and Reports.
• Execution of Equipment Validations (IQs/OQs) and subsequently Process Validation (OQ / PQs).
• Lead NPI development requirements and work with cross functional teams in the Innovation Centre and with the Value Streams.
• Provide design for manufacturing technical input to global design groups to minimise lifecycle cost.
• Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners.
• Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
• Deliver stable manufacturing solutions in line with stability metrics process.
• Management of R&D test parts and sample requests.
• Conduct detailed product design reviews
• Development of advanced manufacturing processes to lean guidelines
• Manage risk management and validation lifecycle for new process or process changes.
• Direct PFMEA studies and lead risk assessment effort for overall process
• Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk
• Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term.
• Provide timely and accurate reporting on project activities.
• All other duties as directed by direct manager.

Candidate Requirements:

• Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline.
• Minimum of three (3) years in product / process development, ideally in Class II / III medical devices.
• Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
• Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem-solving skills.
• Skilled in preparing documentation such as Validation protocols and reports, process documentation, project plans, schedules / timelines and checklists that are often detailed and complex.
• Flexible work ethic. 

DESIRABLE CRITERIA:

• Certification from an accredited institution in Project/Program Management.
• Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
• Proficiency of GD&T and ASME Y14.5M 1994 standards
• Knowledge of anatomy and physiology.
• Knowledge of manufacturing processes.

If you meet our requirements and are interested in hearing more about our Project Engineer role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!