Manufacturing Engineer, Medical Device (12M, Cork)

MANUFACTURING ENGINEER required by CareerWise Recruitment for our medical device client at their facility in County 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 and processes.

No sponsorship is provided for this role so applicants must already have Irish/EU citizenship or the relevant stamp/visa in place.

• Represent the end to end Engineering function as a team member, supporting projects with a focus on Quality, Savings, Capacity, & Validation across the entire product range.
• Prepare several project documents - scoping, design, implementation and execution.
• Support colleagues to complete project related tasks.
• Identify savings on site linked to direct labour inefficiencies, scrap, and consumable spend.
• Ensure new or amended manufacturing process improvements align with operations, quality, EHS, validation, finance, automation and maintenance needs, seeking collaboration and funding from senior leaders.
• Present weekly to senior management on status or funding needs.
• Determine operations & process input and output ranges of machines before validation.
• Conduct installation, operating and performance qualification (IQ, OQ, PQ) of assets and associated machines where appropriate.
• Partner with Quality, Operations, CSV and other cross functional partners to apply design controls, risk management and investigate/correct design failures or challenges.
• Communicate effectively with project managers, other managers, global functions and internal teams on project status, tasks, issues and requirements.
• Provide timely and accurate reporting and manage escalations related to project activities.
• Ensure all activities comply with GMP, ISO and quality system requirements.
• Ensure health, safety and environmental requirements are fulfilled.

• MSc in Engineering or Science with 7+ years of experience in a medium to high volume manufacturing environment.
• 2+ years in a similar capacity in a regulated industry (FDA/ISO).
• Experience working in both an FDA and European regulatory environment, with in depth knowledge of 21CFR820, CFR11 and European medical device regulations.
• Solid understanding of GMP/ISO and validation regulations.
• Technical training in Six Sigma/Black Belt/Lean Manufacturing including Statistics, Lean, Six Sigma methodologies - preferred: Measurement System Analysis, SPC, DOE, reliability.
• Problem solving engineering expertise (Six Sigma, SE or A3).
• Understanding of the mechanical engineering process and process validation expertise.
• Strong verbal and written communication skills.