Senior Process Development Engineer - Advanced Operations

Work Flexibility: Hybrid or Onsite<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Contract</b>: Permanent &#43; full suite of benefits<br /><b>Location:</b> Cork, Carrigtwohill IDA Business &amp; Technology Park Innovation Centre<br /><b>Business Area: </b>Supplier Development <b>- </b>Advanced Operations<br />Hybrid Flexibility<br /> <br /><b>About Stryker</b><br />We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!<br />We are proud to offer you our comprehensive rewards package, which includes bonuses, healthcare, insurance benefits, retirement programs, wellness initiatives, and service recognition programs.</p><p></p><p><b>Position Summary </b><br />Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.</p><p>Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.</p><p>Builds productive internal and external working relationships and may periodically provide guidance and train other team members.</p><p></p><p><b>Key Responsibilities:</b><br />•    <b>Lead Supplier PPAPs (Production Part Approval Process)</b> for various components / complex assemblies, ensuring supplier(s) meet Stryker requirements for NPI.  <br />•    Work with NPI team (Design, Quality, Manufacturing, Operations) and suppliers to develop &amp; agree <b>PPAP</b> plan detailing supplier-specific requirements for part/product characterisation, qualification, and launch readiness, e.g.<br />o    <b>Validation (IQ/OQ/PQ)</b><br />o    Process &amp; quality control activities<br />o    Process capability studies<br />o    Measurement system analysis studies<br />o    Material certifications<br />o    Sample production parts/prototypes<br />o    Environmental compliance REACH / ROHS   <br />o    Manufacturing capacity assessments  <br />o    All other supporting documentation</p><p><br />•    Lead supplier PPAP meetings, drive accountability, technical rigour, and adherence to deliverables.<br />•   <b> Apply lean / six sigma</b> problem-solving methodologies.   <br />•    Input into process technology road-mapping activities and drive innovation to ensure alignment with future planned product launches.<br />•    <b>Work with quality &amp; metrology engineers</b> to develop component-specific testing and inspection protocols. Participate in <b>PFMEA, Control Plan, SOP</b> and <b>PPAP generation </b>associated with product launches.<br />•    Complete First Article Inspections &amp; capability studies for process control and generate subsequent production documentation, ensuring that all activities are completed and documented in accordance with Stryker&#39;s new product development procedures.<br />•    Provide engineering support for new product and process introductions. Provide training to manufacturing team members and other Engineers.<br />•    Ensure adherence to GMP and safety procedures.<br />•    All other duties as assigned.</p><p></p><p><b>Qualifications Knowledge Skills </b><br />•    L8 Bachelor’s degree (or equivalent) in Mechanical, Manufacturing, Precision Engineering or related engineering discipline <br />•   <b> Minimum 2&#43; years of relevant industry experience</b><br />•    Passion for Manufacturing Technology / Supplier Development in a regulated environment.<br />•    <b>Must be able to read and interpret complex engineering drawings</b> and have the ability to understand geometrical dimensioning and tolerancing.<br />•    Excellent interpersonal skills – must be able to express ideas to the wider cross-functional team, collaborate with cross-functional teams to achieve project goals, and be open-minded with the ability to recognise good ideas.<br />•    Innovative thinker - should be able to envisage new and better ways of doing things. Continuous improvement and a Lean Six Sigma mindset are advantageous.<br />•   <b> Experience in executing complex problem-solving techniques </b>related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design. Photonics<br />•    Excellent analytical skills, ability to accurately plan, organise and implement concurrent tasks.<br />•    Good knowledge of manufacturing processes, inspection equipment, materials and process design.<br />•    Experience in an FDA-regulated industry is beneficial.<br />•    Excellent attention to detail.<br />#IJ</p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 20%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>