Medical Device Engineer jobs

Project Engineer

Limerick

About us

Atlantach Technical Services is an engineering solutions company specialising in Project Management, Operations & Maintenance and Commissioning.

Industries we work in

Pharma | Med Device | Datacentre | Automotive | Semi-Conductor

Worldwide Operations

Ireland | Europe | USA

Join Our team

At Atlantach Technical Services, Ambition drives us to continuously improve and grow. Teamwork strengthens our collaboration and respect. Success is achieved together. Join us in shaping your career, where ambition is realised, teamwork is at our core and success is celebrated.

Currently we are hiring a Project Engineer to support our medical device client in Limerick

Duties and Responsibilities:

• Provide engineering support to equipment install upgrades and or new equipment install upgrades
• Define or assist in defining process equipment requirements and specifications based on process requirements, safety requirements and customer needs
• Perform project management tasks for small to medium scale projects involving either new or existing equipment
• Assist in determining the budget to support requirements
• Evaluate or assist in evaluating technology necessary to support requirements
• Propose options to Management/Customer/Stakeholders
• Provide technical support for projects
• Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes and procedures
• Assist in negotiation with equipment suppliers
• Utilize necessary project tools, i.e. URS, Microsoft Project, etc. to manage projects successfully
• Develop the necessary equipment, process and product knowledge to be recognised as a local expert.
• Measure/evaluate equipment efficiencies, downtime and assist in the development of maintenance requirements
• Propose and implement improvement projects that improve compliance, improve efficiencies, yields or throughputs
• Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes
• Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements
• Ensure effective closure on quality system documents (Audit Action, NCR’s, CAPA’s, Maps, etc.)
• Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.
• Vendor Management

Authority:

• You have authority to stop the job if you feel there is an unsafe work practice which could result in a risk of injury, have an environmental impact or risk to equipment and other personnel.
• Carry out your duties to meet Quality, Safety and Environmental requirements at all times.

Requirements:

• Degree or equivalent qualification in production, manufacturing or mechanical engineering.
• 4 years’ experience in relevant engineering role.
• Prior experience in a GMP or medical device manufacturing environment.
• Prior experience in equipment and process validation activities.
• Process development experience.
• Familiar with ISO safety standards.
• Previous experience in the use of ‘black belt’ statistical techniques would be a distinct advantage, as would familiarity with equipment validation in a FDA environment.
• Have statistical process control and capability analysis using ANOVA and DOE techniques.
• Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement.
• Develop good working relationships across the business .
• Ability to motivate and lead - must be team orientated.
• Ability to work on own initiative.
• Good project management and communication skills.
• Attention to detail.

At Atlantach we offer a highly competitive benefits package, including:

• Competitive salary and holiday entitlements.
• Flexible hours and remote working options; role dependant.
• Pension Scheme.
• Healthcare Insurance cover.
• Further education financial assistance.
• Access to a personal financial advisor.
• Bike to work scheme.
• Employee engagement and company-wide events.

Atlantach Technical Services is an Equal Opportunities Employer

ATL1

Benefits:

• Company pension
• On-site parking
• Private medical insurance

Work Location: In person