Senior Quality Manufacturing Engineer
We are looking for a qualified person to Third Level Degree (BSc) in Mechanical Engineering or related discipline with 5 years’ experience in a similar role. Good verbal and written communication skills including protocol / report development and technical presentations. You have experience Risk Management ISO 14971, and Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis. You have experience of design verification &validation test plan development and root cause failure analysis. You have a working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. The following are desirable and not mandatory: You are familiar with the statistical software tools (Minitab, stat graphics, and statistical). You have knowledge of stability, biocompatibility, sterilization & ship testing knowledge. You have a DFSS / Lean Green Belt or Black Belt. You are familiar with IEC 60601, ISO 5361, ISO5366, and product specific industry standards. You will be open for travelling as part of the job (5-10% travel requirements) this position will be based out of Athlone with Global interfaces / support.
Leadership Expectations provide the framework for what we expect from all employees at Medtronic – outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.
SHAPE
We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
■ Demonstrates Global Business Acumen
■ Thinks Critically and Makes Sound Decisions
■ Sets Strategic Direction
ENGAGE
We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
■ Collaborates and Creates Alignment
■ Attracts, Deploys, and Develops Talent
■ Fosters Diversity and Inclusion
INNOVATE
We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
■ Focuses on Patient and Customer
■ Generates Breakthrough Ideas
■ Initiates and Leads Change
ACHIEVE
We do what we say we are going to do, delivering results with the highest standards.
■ Sets High Standards
■ Instils Operational Excellence
■ Drives Accountability
■ Models Ethical Behavior