Senior Project Engineer

Competitive
Contract
Cork
11 Feb 2019
BBBH720993

Requirement for a Senior Project Engineer to develop and install manufacturing processes for new product introductions

JOB PURPOSE:

Development and installation of manufacturing processes and for new product introductions. The successful candidate will provide the technical lead in cross functional teams to set up new processes to meet challenging project commitments in line with agreed stability metrics. The role will involve collaborating with global R&D teams to develop innovative and cost effective devices and delivering highly stable and effective manufacturing processes.

KEY RESPONSIBILITIES:

  • Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners
  • 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
  • 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
  • Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ)
  • 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

QUALIFICATION AND SKILLS REQUIRED:

  • Degree in Mechanical/Production/Manufacturing Engineering and 3 years minimum (Ideally 5 years plus) experience in a medical device or comparable hi-tech environment
  • Proven track record in development, Installation and qualification of manufacturing processes for New Products or Product Transfer
  • Experience using proven problem solving/Root techniques (8D, TRIZ or equivalent)
  • Demonstrated ability to lead sub teams within a project and give direction to fellow team members, contractors, vendors to complete tasks to a defined timeline
  • Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex
  • Self motivated, with focus on Quality, Timelines and Cost
  • Proficiency of GD&T and ASME Y14.5M 1994 standards
  • Excellent Planning & Organizing Skills
  • Flexible work ethic
  • Certification from an accredited institution in Project/Program Management (Desirable)
  • Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements (Desirable)
  • Knowledge of anatomy and physiology (Desirable)
  • Knowledge of manufacturing processes (Desirable)

Morgan McKinley is acting as an Employment Business in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

Juanita Vosloo's picture
Consultant | Engineering Contract Recruitment | Nationwide
Cork, Dublin, Limerick, Waterford 061 430 940 | jvosloo@morganmckinley.ie