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Senior NPI Engineer

Company:
Integer
Location:
Galway, Country: Ireland
Job Type:
Job Description

At Integer, our vision and values are embedded in everything we do!

If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!

JOB SUMMARY:

Self-motivated Manufacturing/NPI Engineering with excellent 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:

Employees are expected to perform their duties in a manner inherent in the guiding principles and philosophies of Lake Region Medical including a variety of job related tasks, which may not be specific to this position profile.

Accountabilities include:

  • Lead or participate in projects to successfully initiate, plan, execute, monitor/control and close significant cross-functional projects in accordance with Lake Region Medical 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.
  • Develop new opportunities through discussion within Sales teams or with customer technical teams.
  • 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.
  • Carryout out design verification and process validation in accordance with Lake Region Medical, ISO and FDA standards.
  • Generate and seeks approval of product and process MVP, IQ, OQ, PQ & PPQ validation protocols and reports.
  • Negotiate with functional managers to acquire project team members.
  • 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 Lake Region Medical.
  • 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.
  • Be an active member of the Lake Region Medical Limited team and work with all employees to develop a world class lean manufacturing system.
  • Comply with the Lake Region Medical Limited behavioral 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, including procurement, inventory control, quality control, production planning and control, test and inspection, layout.

    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.
  • Knowledge of guidewire manufacture and use is a distinct advantage.
  • 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 PRESENCE OR SUPERVISOR:

  • This position reports directly to the Engineering Group Leader.
  • Receives direct supervision and works directly from an Engineering project list.
Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Integer
Company size: 1-49
Contact: NA