Manufacturing Engineer, Medical Device (12M, Cork)

• Initial 12 month contract on offer.
• Role involves development of savings type projects on the Value Capture Program.
• Utilising Engineering principles and Lean problem-solving skills to improve and maintain products/processes.

NOTE: No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.

RESPONSIBILITIES:

• Team member representing the end to end Engineering function supporting projects with a focus on Quality, Savings, Capacity, Validation type projects used in the manufacturing processes across the entire range of products.
• Prepare several documents on the projects – scoping, designing, implementation & execution.
• Support colleagues to complete several project related tasks.
• Responsible for identifying savings on site linked to Direct Labour in-efficiences, Scrap, Consumables spend.
• Ensuring new or amended manufacturing process improvements are aligned with operation's needs, quality, EHS, validation, finance, automation, maintenance requirements, seeking collaboration and funding for the project with Senior Leaders.
• Presentation to Senior Management Weekly on Status or need for funding.
• Determine operations & process inputs and outputs ranges of machine prior to commencing validation.
• Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ, OQ, PQ) of assets and associated machines.
• Partner with Quality, Operations, CSV and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
• Communicate effectively with project manager and other managers, global functions and internal team on status of project (s) tasks, issues and requirements.
• Provide timely and accurate reporting and management of escalations as appropriate on project activities.
• Ensure all activities comply with GMP, ISO and quality system requirements.
• Ensure that all health, safety and environmental requirements are fulfilled.

EDUCATION & EXPERIENCE

JOB REQUIREMENTS

ESSENTIAL:

• MSc in Engineering or Science with 7+ years’ experience in a medium to high volume manufacturing environment.
• 2+ years in a similar capacity in a regulated industry (i.e. FDA/ISO)
• Work from the office to hands on with fellow Engineer’s development of trials, experiments, development of projects.

DESIRABLE:

• Experience working in both an FDA and European regulatory environment is preferred with an in-depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
• A thorough understanding of GMP/ISO and validation regulations.
• Technical training Six Sigma/Black Belt/Lean Manufacturing experience projects using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Problem solving engineering expertise (Six Sigma, SE or A3)
• Understanding of the Mechanical Engineering process and Process Validation expertise is preferred
• Strong verbal and written communication skills

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie

Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.