Job Description
We are currently recruiting for an exciting opportunity with a leading medical device organization based in Cork. This is an excellent position for anyone looking to join a multinational company that excels in its field.
Duties:
* Lead New Product Introduction (NPI) development requirements and collaborate with cross-functional teams in the Innovation Centre and Value Streams.
* Provide design for manufacturing technical input to global design groups to minimize lifecycle costs.
* Develop project plans to deliver projects against agreed milestones and project scope, including schedule, resources, and cost.
* Deliver stable manufacturing solutions aligned with stability metrics processes.
* Conduct and lead detailed product design reviews.
* Develop advanced manufacturing processes in line with lean guidelines.
* Manage risk management and validation lifecycles for new processes or process changes.
* Oversee asset lifecycles for new equipment and processes, including User Requirements Specification (URS), Risk Assessment (RA), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Direct Failure Mode Effects Analysis (FMEA) studies and lead risk assessment efforts for overall processes.
* Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure models and overall risk.
* Develop strategic collaborations across functions, business units, and geographic boundaries to achieve effective long-term outcomes.
* Provide timely and accurate reporting on project activities.
* Perform other duties as directed by direct manager.
Education & Experience:
* Hold a degree in Mechanical/Production/Manufacturing Engineering and have a minimum of 3 years' postgraduate experience in a medical device or comparable high-tech environment (ideally 5+ years).
* Demonstrate a proven track record in developing, installing, and qualifying manufacturing processes for new products or product transfers.
* Experience using proven problem-solving/root cause analysis techniques (8D, TRIZ, or equivalent).
* Possess certification from an accredited institution in Project/Program Management.
* Have knowledge of medical device quality and regulatory systems, including the Medical Device Directive (ISO13485, MDD, and FDA CFR 820), and other pertinent Design Control requirements.