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Job ID: JOB-12222

Process Development Engineer

This is one of those exciting Process Development Engineering job opportunities that just stands out from the crowd!  If you’ve been considering a career move then this is well worth your time exploring, it will be hard to top on salary package and career growth.

Located 20 minutes outside of Galway City, you will be working in a super culture along with a great leadership team who genuinely care about their people’s well-being and career progression. 

About the Role:

Due to exciting growth on a number of new products, in 2022, our client requires a number of proven candidates with a background in Quality and Manufacturing Operations, to support medical device qualification and continuous improvement projects. Candidates must have a minimum of 3 years post qualification experience in a Quality Engineering or Manufacturing Engineering Medical Devices environment. The role will be cross functional and will require interaction with many R&D, manufacturing engineering, maintenance, EH&S, quality engineering, and supply-chain functions.

The successful candidates will hold leadership roles in maintaining high quality/ performance/ safety standards on all assigned implant-products platforms. Reporting to the Engineering Manager, the positions will be challenging but rewarding and will involve exposure to the latest Tier1- company implant product-designs and will require an ability to work autonomously.

Duties and Responsibilities:

• Work on New Product Development as part of a cross-functional team, provide Quality Engineering technical direction/input to process development.
• Drive and lead qualification / validation efforts as defined in Validation Master Plan, including qualifying equipment, validating processes, data analysis, risk assessment, and monitoring of ongoing inspection activities. Provide complete, accurate, and well-organized documentation for requirements, plans, reports, PFMEA’s, checklists, etc. in conjunction with the validation team.
• Function effectively as part of cross functional teams; develop strong partnering relationships within these groups and provide constructive feedback and quality leadership.
• Understand product construction, features, and uses at a highly competent level to contribute to decision making process on product acceptance standards within their scope of responsibility.
• Lead or support root cause investigations; drive problem solving efforts of quality issues.
• Support the introduction/implementation of process/materials changes to the manufacturing operation. You will assess the impact on process validation for these changes.
• Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.
• Lead medium-to-large scale cross-functional project teams and projects to successful outcomes.
• There will be a strong linkage with the Quality Assurance department in supporting the Compliance requirements of an ISO13485 organisation. This will encompass NCR and CAPA ownership and resolution.

Key Requirements for the Role:

• We are looking for a person qualified to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
• Candidates must have a minimum of 3 years post qualification experience in a Quality Engineering or Manufacturing Engineering role, leading new products introduced into a commercial state, leading continuous improvement and compliance support within an ISO-8 (or higher) clean environment.
• You are a dynamic team player, highly motivated and passionate and can work effectively and proactively on cross-functional teams.
• Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability, Thinks Critically and Makes Sound Decisions.
• Strong familiarity with FDA GMP/QSR; ISO 13485, and medical standards is essential.
• Knowledge of statistical requirements is an advantage.
• You are a good communicator and fluent in English, both in writing and speaking.

For further information on this role please contact Tommy McKeown on 086 0100903  / jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Tommy McKeown

JOB-12222

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