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Project Engineer (NPI)

  • Job reference: 929297
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 13/01/2020

Orion Group Sciences are looking for a Project Engineer (NPI) for our multinational medical devices client based in the Cork area on an initial 12-month contract with the potential to extend.

Job Purpose

Key member of an NPI Engineering project team to develop, qualify & launch a manufacturing process capable of repeatedly making new products to safety, quality, service and cost standards.

Main Responsibilities of the role

  • 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 onsite 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

Desired Experience and Background of the successful candidate

  • 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
  • Prior experience in a GMP or medical device manufacturing environment
  • Prior experience in equipment and process validation activities
  • Process development experience
  • Equipment conceptual skills
  • Experience of bespoke capital equipment
  • 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
  • Conscientious, self-directed and motivated
  • Organised and results orientated
  • Ability to take ownership
  • Develop good working relationships across the business
  • Ability to motivate and lead - must be team orientated

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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