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Job ID: JOB-12648
Process Development Engineer

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

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Tommy McKeown

JOB-12648

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