About this role
<div> <table align="left"> <tbody> <tr> <td style="padding:0.0in 12.0px 0.0in 12.0px" align="left" valign="top"> <p><span style="font-family:verdana, geneva, sans-serif"><strong>Responsibilities:</strong></span></p> <div> <table align="left"> <tbody> <tr> <td style="padding:0.0in 12.0px 0.0in 12.0px" align="left" valign="top"> <ul> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Lead design changes for existing products driven by material obsolescence, supply risk mitigation, dual sourcing, and cost optimization, in alignment with business strategy and regulatory requirements.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Plan, coordinate, and drive end-to-end change activities, including scope definition, timeline management, risk identification, and stakeholder alignment across cross-functional teams.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Collaborate closely with R&D, Quality, Manufacturing, and Supply Chain to ensure smooth execution of design changes, sample builds, qualification, and implementation activities.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Manage technical aspects of sourcing materials, components, tooling, and parts from suppliers; ensure specifications, quality, and regulatory compliance are met.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Evaluate and qualify new materials, suppliers, and tooling to support sustaining, dual sourcing, and supply continuity initiatives.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Develop, execute, and document test plans and validation strategies; perform root cause analysis for material- or supplier-related failures.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Generate technical justifications and risk assessments to optimize qualification approaches, including testing scope and representative sample selection.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Identify and drive cost reduction opportunities through material optimization, re-specification, and design improvements.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Re-engineer products in accordance with design change procedures to improve cost efficiency while maintaining product quality, reliability, and performance.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%"> Support implementation and industrialization activities, including process validation (PCS, IQ, OQ, PQ), sample builds, and production readiness.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%">Troubleshoot material and process-related issues in manufacturing and evaluate alternative process windows when required.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%">Ensure all activities are documented in accordance with quality management system (QMS) and regulatory requirements.</span></span></li> <li style="line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="line-height:107%">Coach and mentor junior Materials Engineers as needed.</span></span></li> </ul> </td> </tr> </tbody> </table> </div> <p> </p> <p><strong><span style="font-family:verdana, geneva, sans-serif">Requirements:</span></strong></p> <ul> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:verdana, geneva, sans-serif">Strong technical/engineering expertise with in-depth knowledge of medical device standards; ISO 13485 knowledge is preferable. </span></li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:verdana, geneva, sans-serif">Bachelor’s degree in Materials engineering, Mechanical Engineering, Biotechnology, Biomedical Engineering, or a related engineering discipline relevant to the medical industry. </span></li> <li style="font-family:verdana, geneva, sans-serif;font-size:10.0pt"><span style="font-size:10.0pt;font-family:verdana, geneva, sans-serif">Minimum 3–5 years of relevant working experience, with a proven track record of achievements in the field.</span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Detail-oriented, organized, capable of delivering high quality work.</span></span></span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Enthusiastic about medical devices manufacturing industries.</span></span></span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Possess strong analytical & problem-solving skill.</span></span></span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Innovative and out of box thinker.</span></span></span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Independent, dedicated with a high sense of integrity.</span></span></span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Strong initiative and ability to work in self-directed and teamwork environment.</span></span></span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Willing to go extra miles to achieve department KPIs, result oriented. </span></span></span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="vertical-align:baseline"><span style="font-family:'Times New Roman', serif"><span style="font-family:'Verdana', sans-serif"><span style="color:black">Ability to work collaboratively across multi-functional teams.</span></span> </span></span></span></li> <li style="font-size:10.0pt"><span style="font-size:10.0pt"><span style="font-family:'Verdana', sans-serif">Positive mindset and can-do attitude.</span></span></li> </ul> </td> </tr> </tbody> </table> </div>