Lake Region Medical
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IRELAND OPPORTUNITIES
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Current International Openings:
Temporary Director of Operations, Penang
 
Current Openings in New Ross:
Quality Engineer
 
Current Openings in Galway:
Product Development Engineer
Design Assurance Engineer
Manufacturing Engineer
 
Lake Region is proud to be an equal opportunity employer. We are always seeking talented, motivated, and innovative people to join our dedication to delivering precision products to minimize patient suffering.
 

Quality Engineer
Reports to: Senior Quality Engineer
Location: New Ross, Ireland

JOB SUMMARY:
The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.

DUTIES AND RESPONSIBILITIES:

  • Ensure continued compliance with all Regulatory Standards. This includes:
    • ISO 13485
    • FDA QSR
    • ISO 14000 and ensuring continued compliance with DMR
  • Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
    • Trend analysis of data from the controls
    • Potential improvements for review with engineering based on the trends.
    • Areas for Improvement to senior management.
    • Review and propose changes to sampling plans based on trend analysis and changes to the system.
  • Support the RCA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
  • Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
    • Validations.
    • Engineering Change Order (ECO).
    • Request for Corrective Action (RCA).
    • Material Review Request (MRR).
    • Internal Audits.
    • Failure Mode Effect Analysis (FMEA).
    • Variation Permits (VP).
  • Project meeting attendance as required.
  • Attend and participate in daily cell meetings.
  • Preparation of information for KPI and Management Review meetings.

SKILLS AND KNOWLEDGE:

  • Ability to communicate and work with people inside and outside the department.
  • Knowledge of engineering theories and methods.
  • Good technical report writing skills and rigorous attention to detail.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

  • Engineering or science degree preferably with Quality Engineering included.
  • Minimum of 2-3 years experience

Interested applicants should submit their application in writing together with cover letter and cv to Siobhán Woods in the HR Department at Siobhan.Woods@lakeregionmedical.com

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Temporary Director of Operations, Penang
Department: Engineering
Location: Malaysia
Duration:
6 – 12 Month Contract

JOB SUMMARY:
The Director of Operations for our Penang site will have 10+ years of demonstrated leadership experience in a world class manufacturing environment. He/she will have a proven track record of product transfers.  He/she will have full responsibility for all functions within the Penang site.

The Lake Region Medical Operations Team is responsible for overseeing the financial performance as well as the productivity, quality, and efficient delivery of products and services by ensuring departments within operations work together and with the wider company in order to ensure world class service to our customers. Operations will implement policies and procedures for planning, goals and business objectives, make recommendations, and execute improvement efforts, as well as, continuously work to improve departmental workflow.

The Director of Operations will have accountability for the profit and loss of the location and will provide support for generating new business in addition to manufacturing existing products. He/she will lead safety, quality, environmental compliance, cost, delivery and responsiveness performance, equipment maintenance, manufacturing engineering, product introductions and continuous improvement performance of the facility/s that they manage. He/she will be responsible for the development of the facility leadership team.

RESPONSIBILITIES:

  • Support the long term vision and goals for the site.  
  • Responsible for the overall Profit and Loss of Penang and accountable for achieving EBITDA growth targets and maximum return on invested capital by continuously improving yr on yr Financial performance metrics. This will be done in coordination with the Finance function 
  • Lead and coordinate Manufacturing Engineering, Manufacturing, Facilities, EH&S Continuous Improvement, HR, Planning and to continuously improve yr on yr Quality performance metrics. This will be done in coordination with the Quality function.
  • Lead the Continuous Improvement culture and training for the location including methods & tools, behaviors and problem solving consistent with the LEAN principles established by Lake Region Medical. Create and lead a culture of continuous improvement, installing and successfully executing advanced visual, flow manufacturing systems, structured problem solving, world class maintenance systems, standard work, roll out of behavioral standards, etc. This includes actively seeking best practice across the site and from the wider CI practicing community and pull these practices into and embed them into the Penang site.
  • Create strategies for all operational functions including supply chain, production, manufacturing engineering, NPI, CI, and HR to deliver world class products and services now and into a growingly competitive future to ensure continuous performance of the site.
  • Support and jointly lead the Product Introduction function for the site including business, technical, and business process oversight. This critical role requires coordination of business risk, technical uncertainty and customer communication in partnership with the sales team in a way that minimizes time to profit and minimizes disruption to the existing business.
  • Develop annual financial plans with the Financial Planning and Analysis function to support continuous growth and cost improvements. Provide Monthly Operational performance summaries inclusive of a 12 month rolling financial forecast to achieve EBITDA performance to changing revenues and product mix. This includes developing justifications and plans for investments in training, staffing, and capital equipment.
  • Participate in Sales Development by working directly with CAD’s and the VP, Sales to develop customer relationships and close sales.
  • Support Customer Operations activities within the facility including quoting and customer service.
  • Recommends and executes personnel actions including hiring, promotions, performance reviews and any disciplinary measures.
  • He/she is responsible for the engagement scores of the Penang site and ensuring continuous improvement in this area.
  • Complies with all work rules including those pertaining to safety, health, environmental compliance quality, and Lake Region Medical Quality Management System.
  • Performs other duties as necessary.

REQUIREMENTS:

  • BS Engineering, MBA and appropriate continuing education
  • Minimum 10 years leadership experience in a world class manufacturing environment
  • Proven track record in product transfers.
  • Demonstrated P&L management experience in a technically driven environment
  • Knowledge of complex manufacturing to include machining, metals processing, fabrication and product assembly.
  • Must have demonstrated success in leading new process development and new product launch systems.
  • Working knowledge of capacity planning and logistics management.
  • Demonstrated ability to manage complex manufacturing technologies and developing financial plans to make technology investments return positive financial returns.
  • Demonstrated leadership, employee engagement and team building skills across multiple sites
  • Ability to interface with customers, problem solve and drive solutions to meet customer requirements.
  • Knowledge of FDA Good Manufacturing Practices, ISO 13485-2003, 510k and medical regulatory issues
  • Lean Manufacturing and continuous process improvement experience
  • Strong communicator: written and verbal (one-on-one and group)
  • Strategic thinker: responsible for developing the plan; ability to conceptualize coherent view of facility in the future (6 months, one year, two years, five years)
  • Willingness  to travel globally
  • Ability to analyze, understand and effectively communicate deep technical material 

Interested applicants should submit their application in writing together with cover letter and cv to Siobhán Woods in the HR Department at Siobhan.Woods@lakeregionmedical.com

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Product Development Engineer
Location:Galway, Ireland
Department: Engineering
Reporting to:
Senior Project Engineer

JOB SUMMARY:
The R&D Project Engineer will typically manage product and/or process development projects through the design life-cycle. In addition, the role is required to provide support to manufacturing in the resolution of design related issues

DUTIES AND RESPONSIBILITIES:

  • Project manage all aspects of new product introduction from concept through to design transfer.  Functions include:
    • Defining new product functional and performance requirements
    • Developing FMEAs (design and process)
    • Manage prototype build and testing
    • Developing packaging and labeling designs
    • Updating and maintaining the design history file for each new product
    • Preparation of Regulatory submissions

SKILLS AND KNOWLEDGE:

  • Knowledge of engineering theories, methods and work measurement techniques.
  • Ability to apply engineering methods in the definition, design, research, development, utilisation, maintenance, and cost-control of processes and equipment to build Lake Region products and improve qualities and reduce costs of such processes and products.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS

  • Minimum of Bachelor’s degree in Engineering, ideally with relevant industrial experience.
  • Experience working with guide wires and catheters advantageous.

Interested applicants should submit their application in writing together with cover letter and cv to Niall Harris in the HR Department at niall.harris@lakeregionmedical.com

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Design Assurance Engineer
Location:Galway, Ireland
Department: Quality
Reporting to:
Regulatory Affairs and Design Assurance Manager OUS

JOB SUMMARY:
The Design Assurance Engineer will be responsible for the Installation, Validation and Maintenance of standard test methods at Lake Region Medical, Galway. This role will provide support to the R&D and Production groups through product test and characterisation. In addition, the Engineer will liaise with the R&D group to develop test methods as required by new projects.

DUTIES AND RESPONSIBILITIES:

  • Maintenance of test lab including:
    • Product benchmark testing to design file results
    • Failure investigation activities (internal and FER issues).
    • Upkeep and introduction of new test methods as required.
    • Validation testing for process changes.
  • Project management.
  • Transfer of new test methods and equipment

SKILLS AND KNOWLEDGE:

  • 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 in the definition, design, research, development, utilisation, maintenance, and cost-control of processes and equipment.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS

  • Degree in Engineering/Science, with 1-3 years experience

Interested applicants should submit their application in writing together with cover letter and cv to Niall Harris in the HR Department at niall.harris@lakeregionmedical.com

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Manufacturing Engineer
Location: Galway, Ireland
Department: Manufacturing Engineering
Reporting to:
Senior Operations Engineer

JOB SUMMARY:
Provide engineering support to production through improved methods, processes, jigs and fixtures, tooling and machine enhancements to improve standard times and employee efficiencies in order to manufacture quality medical guide-wires at the target costs. Validate and introduce new equipment and processes to production.

DUTIES AND RESPONSIBILITIES:

  • Providing technical support to production.
  • Lead or participate in projects, working closely with Production, Maintenance and Quality departments.
  • Employ Lean Manufacturing and Six Sigma methodologies such as process mapping, control charting, as appropriate in project work.
  • Monitor manufacturing activities, measure significant process characteristics and analyse variation in order to detect and reduce waste / scrap.
  • Project management using standard Lake Region methodology.
  • Transfer of New Products to production, both within and between sites.
  • Process and product validation.
  • Providing technical online support to production.

SKILLS AND KNOWLEDGE:

  • Experience in production environment and processes.
  • Ability to communicate and work with people inside and outside the Department as necessary to execute responsibilities.
  • Knowledge of manufacturing operations, systems and project management, including procurement, inventory control, quality control, production planning and control, test and inspection, layout.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS

  • College graduate with degree in Engineering , with 2-3 years experience in a manufacturing engineering role

Interested applicants should submit their application in writing together with cover letter and cv to Niall Harris in the HR Department at niall.harris@lakeregionmedical.com

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Contact

To apply for a posted position, send your resume and cover letter to:

New Ross Positions:
Siobhán Woods
MAIL:
Lake Region Medical Limited
Butlersland, New Ross
County Wexford Ireland
EMAIL:
Siobhan.Woods@lakeregionmedical.com

Galway Positions:
Niall Harris
MAIL:
Lake Region Medical International
Research and Development Centre
Parkmore West Business Park
Galway, Ireland
EMAIL:
niall.harris@lakeregionmedical.com

Contact
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