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NPI Engineer 1 (parkmore Galway)

Lead the development and validation of new medical device manufacturing processes
Dundonald, Northern Ireland, United Kingdom
Mid-Level
yesterday
Integer Holdings Corporation

Integer Holdings Corporation

A global leader in medical device outsource manufacturing, providing innovative solutions for cardiac, neuromodulation, and other medical technologies.

3 Similar Jobs at Integer Holdings Corporation

Engineer Position

Self-motivated Engineer with good communication, organisation and co-ordination skills to lead and or support the initiation, planning, execution and monitoring/control of assigned projects and provide engineering support to production through continuous improvement methodologies.

Essential Job Duties and Responsibilities:

  • Lead or participate in projects to successfully initiate, plan, execute, monitor/control and close significant cross-functional projects in accordance with Integer project management policies and procedures.
  • Delivering engineering projects to scope, schedule and cost baselines.
  • Participate in group brainstorming sessions to feed new project pipeline.
  • Manage the Asset Lifecycle for new equipment (URS/RQ/IQ/OQ/PQ/PPQ).
  • Responsibility for project capital and expense spend.
  • Undertake in-depth feasibility studies to support new project business case, SOW and funding for the procurement of capital equipment.
  • Responsibility for driving customer initiated projects forward.
  • Responsibility for New Product Introduction projects from initial customer contact and specification review to creation of production documentation including, routings, boms, drawings, labels etc.
  • Carry out design verification and process validation in accordance with Integer, ISO and FDA standards.
  • Generate and seeks approval of product and process MVP, IQ, OQ, PQ & PPQ validation protocols and reports.
  • Deliver continuous improvement projects through Root Cause Analysis methodologies, A3 problem solving, Kiazen events and value stream mapping.
  • Support the quality concepts inherent in the business philosophies of Integer.
  • Create and maintain Device Master Record (DMR) Documentation through the order entry and ECO 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.
  • Assist in training employees in new or improved processes.
  • Sourcing, specifying and purchasing production equipment.
  • Jigs and fixture specification and development.
  • Assist in the specification of spare part lists.
  • Comply with company behavioural standards.

Skills and Knowledge:

  • Ability to communicate and work with people inside and outside the Department as necessary to execute these responsibilities.
  • Ability to train and lead assigned team members.
  • Ability to understand and follow appropriate Departmental policies, procedures, practices and to understand inter-relationships of people and functions.
  • Knowledge of manufacturing operations, systems and project management
  • Knowledge of engineering theories, methods and work measurement techniques.
  • Ability to apply engineering methods to deliver assigned projects to scope, schedule and cost baselines.
  • Ability to work in a fast-paced, multi-tasking role.
  • Ability to manage projects effectively.
  • Awareness of personal effectiveness
  • Leadership skill training beneficial

Minimum Education and Experience Requirements:

  • College graduate with degree in Engineering, or equivalent experience.

Physical Demands:

  • Work effectively with close tolerance.

Mental Demands:

  • Ability to work in an organised fashion.
  • Attention to detail.
  • Self-starter.

Working Conditions:

  • Day-shift operation, but may be required to change working hours or work other shift patterns occasionally as project responsibility dictates.

Reporting Relationship and Supervisor:

  • This position reports through engineering function

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

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NPI Engineer 1 (parkmore Galway)
Dundonald, Northern Ireland, United Kingdom
Engineering
About Integer Holdings Corporation
A global leader in medical device outsource manufacturing, providing innovative solutions for cardiac, neuromodulation, and other medical technologies.