Careers

Career opportunities with VistaMed and Helix Medical

Ref: PAO01 Process Assurance Operators (VistaMed)

Ref: ET01  Extrusion Technician (VistaMed)   

Ref: QE01  QA Engineer, VistaMed   

Ref: QVE01 QA Validation Engineer, VistaMed   

Ref: PDE01 Product Design Engineer / Project Leader, VistaMed

Ref: PDE02 Senior Product Design Engineer , VistaMed

Ref: PEA01 Process Engineer Assembly, VistaMed

Ref: PEE01 Process Engineer Extrusion, VistaMed

Ref: ME1101 Silicone Process Engineer, Helix Medical

 

 

Ref: PAO01

Job Title/ Position:
Process Assurance Operators (VistaMed)
 

Required Qualifications/Experience/Skills:

  • Interview Selection based on experience, aptitude & references.

Basic Responsibilities:

  • Ensuring that Plant Safety Requirements are adhered to.
  • Ensuring that all cleanroom, housekeeping & GMP requirements/ procedures are adhered to.
  • Ensuring that product is manufactured in accordance with Customer / VISTAMED procedures & blueprints while meeting pre-determined internal quality & productivity goals.
  • Ensuring that all process control requirements are adhered to including first piece inspection , in-process inspections and that timely adjustments are carried out , in accordance with production procedures.
  • Ensuring that product change-overs are carried out effectively and waste reduction methods are integrated into all processes.
  • Take action where necessary to highlight and prevent product and process non-conformances in accordance with our non-conforming procedure.
  • Participation in Customer Complaint investigation & resolution.
  • Participation in plant Corrective Action & Continuous Process Improvement programmes.
  • Participation in the Internal Training Programme.
  • Participation in the Internal Quality Audit Programme.

 

 

Ref: ET01

Job Title/ Position:
Extrusion Technician (VistaMed)
 

Required Qualifications/Experience/Skills:

  • Certification in Polymer Science or Mechanical Engineering.
  • Experience in extrusion of medical tubing including multi-lumen, co-extrusions, thin wall tubing, tight tolerance tubing, etc.
  • Experience and knowledge of medical device environment including Clean room manufacture, validations, process controls, etc.
  •  

Basic Responsibilities:

  • Clean down and set up extrusion lines in adherence of line cleaning procedures and process set up in Work Orders and Work Instructions.
  • Dry materials, as required, and load to hoppers. Carry out moisture checks as required.
  • Size tubing to meet customer and VistaMed dimensional, functional and visual specifications.
  • Ensure First Article inspections are completed.
  • Monitor production and adjust extrusion parameters within acceptable ranges to optimise tubing quality ensuring tubing is run as close to nominal as possible unless instructed otherwise.
  • Complete documentation or ensure documentation is completed including process parameter monitoring and in process inspection.
  • Shut down extruders at the completion of run, finalise and sign documentation and ensure tubing is packaged and labelled correctly.
  • Develop process, either on own or with Process Engineers for new tubes. For simple, similar tubing with known materials, the extrusion technician can develop the process on their own. For more complex tubes or materials assist Process Engineers to develop process.
  • Ensure that all production and processes are run as cost effectively as possible:
     Minimise set up and sizing times.
     Minimise waste of resins, defect tubing etc.
     Minimise process variability and ensure that tubing is run at nominal as far as practical unless otherwise instructed
     Maximise run speeds within parameter and process stability constraints.

 

 

Ref: QE01

Job Title/ Position:
QA Engineer (VistaMed)
 

Required Qualifications/Experience/Skills:

  • Third level Qualification in Engineering in Manufacturing/Quality with emphasis on Medical Devices / Biomedical
  • 2-3 years previous experience as Quality/Validation Engineer in Medical Device / Pharma environment.
  • Fully PC literate, use/knowledge of Minitab would be beneficial.
     

Basic Responsibilities:

  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13485, other applicable regulatory standards and customer requirements. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC when appropriate.
  • Completion of Validation Programme – Risk Analysis (FMEA), VMP, IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures.
  • Working with the various customers to agree on quality requirements for the products, discuss and resolve issues as they occur during the product development phase.
  • Work with the other members of the project team to ensure the process is established and validated to the required standards.

 

 

Ref: QVE01

Job Title/ Position:
QA Validation Engineer (VistaMed)
 

Required Qualifications/Experience/Skills:

  • Third level Qualification in Engineering / Manufacturing / Polymers / Plastics with emphasis on Medical Devices / Biomedical
  • 2-3 years previous experience as Quality/Validation Engineer in Medical Device Environment preferably.

Basic Responsibilities:

  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13485. Generation of Product Technical Files & associated studies in accordance with MEDDEV 93/42/EEC when appropriate.
  • Completion of Validation Programme – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures

 

 

Ref: PDE01

Job Title/ Position:
Product Design Engineer / Project Leader (VistaMed)

Required Qualifications/Experience/Skills:

  • Third level Qualification in Engineering in Manufacturing with emphasis on Medical Devices / Biomedical
  • Project Management
  • Minimum of 3 years. previous experience in design and development of Catheters in a Medical Devices / Healthcare Environment.

Basic Responsibilities:

  • Co-ordination & maintenance of New Product Introductions to include product design, product specifications, identification of training needs, process & equipment lay-out, production procedures, material specifications, material & packaging procurement in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC and VistaMed Quality Procedures.
  • In conjunction with Process Engineering and Production, develop new assembly process and ensure that the new processes are capable and repeatable.
  • Interface with customers and suppliers on Project matters, tooling and equipment design, material sourcing, quality issues and process development.
  • Responsible for Project Planning and Control for assigned projects.

 

 

Ref: PDE02

Job Title/ Position:
Senior Product Design Engineer (VistaMed)

Required Qualifications/Experience/Skills:

  • Engineering Qualification in Design, Polymer, Medical, Mechanical, Biomedical or equivalent
  • Minimum 5 years experience in Catheter and Medical Device design and extensive knowledge on the use and requirements for Catheter design
  • Comprehensive knowledge of resins, materials, packaging and other components required for Catheter and Medical Device Design
  • Comprehensive knowledge of the manufacturing processes used for manufacturing catheters used within the Neurovascular together with stent delivery systems for the Cardiovascular and Peripheral vascular areas, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.

Basic Responsibilities:

  • Designing innovative catheters and Medical Devices. Selection and design of materials, components, tubing and packaging.
  • Working with the New Product Introduction teams to ensure Product Designs include DFM (Design for Manufacture) and can be manufactured at competitive costs.
  • Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design History Files in accordance with VistaMed procedures and Regulatory Standards.
  • Leading or participating in design tasks such as clinical trials, functional studies, testing including biocompatibility, aging, design verification, etc.
  • Compliance with FDA and ISO standards for Catheters and Medical Devices.

 

 

Ref: PEA01

Job Title/ Position:
Process Engineer Assembly (VistaMed)

Required Qualifications/Experience/Skills:

  • Third level Qualification in Engineering in Manufacturing with emphasis on Medical Devices / Biomedical
  • Minimum of 3 years. previous experience in process development and manufacturing of Catheters in a Medical Devices / Healthcare Environment.
  • Have demonstrated a capacity to optimise manufacturing processes.

Basic Responsibilities:

  • Development and validation of new processes for new and existing products including tooling and equipment as required for assembly and packaging of catheters in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC and VistaMed Quality Procedures.
  • Provide Engineering and Problem Solving support for Production on existing products and processes.
  • Interface with suppliers on tooling and equipment solutions, material processing and process development.

 

 

Ref: PEE01

Job Title/ Position:
Process Engineer Extrusion (VistaMed)

Required Qualifications/Experience/Skills:

  • Third level Qualification in Engineering in Polymer Science
  • Minimum of 3 years previous experience in extrusion tooling and process development of medical tubing especially related to high end extrusions (multi-lumen, co-extrusion, tight tolerance, thin wall, etc).

Basic Responsibilities:

  • Development and validation of new processes for new and existing products including tooling and equipment as required for medical tubing in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC and VistaMed Quality Procedures.
  • Provide Engineering and Problem Solving support for Production on existing products and processes.
  • Interface with suppliers on tooling and equipment solutions, material processing and process development.

 

 

Ref: ME1101

Job Title/ Position:
Silicone Process Engineer  (Helix Medical)
Carpenteria, CA. Helix Medical Website: www.helixmedical.com
 

Required Qualifications/Experience/Skills:

  • Third level Qualification in Engineering
  • Minimum of 3 years technical experience in injection moulding and related mould design. Experience of liquid silicone rubber (LSR) would be a distinct advantage.
  • Previous experience working in a medical or healthcare manufacturing environment.
  • Experience with Scientific Injection Moulding Principles
  • Experience using SolidWorks, preferably CAD experience in 2D dimensioning and 3D solid modeling

Basic Responsibilities:

  • Maintain complete and accurate records of assigned project activities per established Quality System
  • Maintains documentation for all internal processes, inspection criteria, Bill of Materials and other manufacturing and quality records
  • Operates within the manufacturing unit to support production on injection moulding of Liquid Silicone Rubber (LSR) materials.
  • Interfaces with customers and suppliers on project matters, mould and fixture design, process capability studies, product quality issues and executes on automation related projects.
  • Conduct internal audits and assists with maintaining the Quality System to ISO 13485 standards

 

 

 

If you are interested in finding out more, then forward your c.v. or resume (in strict confidence) quoting job reference to:

Human Resource Department
Vistamed Ltd,
IDA Business & Tech Park,
Carrick-on –Shannon,
Co Leitrim

Tel No: 071 9638833
Fax No: 071 9671345
E-mail: hr@vistamed.net

VistaMed Ltd and Helix Medical are equal opportunities employers