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Staff Process Development Engineer

Job Title: Staff Process Development Engineer
Contract Type: Permanent
Location: Cork
Industry:
REF: 86494
Job Published: 8 months ago

Job Description

Contact: Roisin McNamara
Email: roisin@hero.ie
Telephone: 091730022

Staff Engineer
Our client, a medical device company in Cork are currently looking to recruit a Staff Engineer for their site.

Job Title
Staff Engineer, Advanced Operations
Reports To
Senior Staff Engineer, AO Additive

Position Summary
  • Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
  • Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
  • Builds productive internal and external working relationships and may periodically provide guidance and train other team members.

Key Areas Of Responsibility
  • Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the companies new product development procedures.
  • Ensure quality of process and product as defined in the appropriate operation and material specifications.
  • Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
  • May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
  • Will analyse equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
  • Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
  • Complete capability studies for in process inspection and generate subsequent Inspection documentation.
  • Conduct MSA studies for new products and new processes.
  • Provide training for manufacturing team members.
  • Ensure adherence to GMP and safety procedures.
  • Review and approval of validation documentation.
  • All other duties as assigned.

Qualifications Knowledge Skills
  • B.S in Mechanical Engineering or related engineering discipline with 4 or more years' experience or a related master's degree.
  • Proven track record of working in a team based environment.
  • Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.
  • Innovative thinker - should be able to envisage new and better ways of doing things.
  • Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
  • Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
  • Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
  • Good knowledge of manufacturing processes, materials, product and process design.
  • Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
  • Certified in validation activities.
  • Experience in an FDA regulated or regulated industry beneficial.
  • High level of PC Skills required.
  • Excellent attention to detail.


For further information on this Staff Engineer role in Cork please contact Roisin McNamara on 091730022 / roisin@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie

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