Job
Description
Role Overview: As an engineer in this role, you will be responsible for designing and developing mechanical components and systems in the medical device domain. You will work on multiple projects simultaneously in product engineering, including tasks such as gap assessments, design changes, manufacturing transfers, product development, and regulatory or business-driven projects. Your focus will be on deriving or remediating design requirements and engineering specifications that meet user needs. Additionally, you will be involved in creating or remediating technical documents such as Design History Files and Device Master Records. Key Responsibilities: - Design and develop mechanical components and systems in the medical device domain - Work on multiple projects simultaneously in product engineering - Derive or remediate design requirements and engineering specifications - Create or remediate technical documents including Design History Files and Device Master Records - Drive engineering changes through proper planning and analysis - Carry out engineering analysis through simulation, design of experiments, and engineering calculations - Liaise with lab team to carry out verification and validation activities - Collaborate with divisional partners to drive projects within schedule, cost, and quality baselines - Involve in technical discussions with stakeholders globally - Execute NC CAPA, implement design controls, and risk controls Qualifications Required: - Master's or Bachelor's degree in Engineering, Mechanical Engineering - Minimum of 3 years of work experience - Strong technical ability in creating engineering drawings and models, applying GD&T and CAE tools - Skilled in interpreting design, analyzing, and performing DFM, DFI, materials, and manufacturing - Ability to communicate moderate complexity plans and technical information to team members - Experience and knowledge of plastic films and film blown extrusion process preferred - Good working knowledge of CAD applications (Creo/SolidWorks/UniGraphics) - Experience with analysis tools, specifically tolerance analysis and FEA using ANSYS software preferred - Strong knowledge of soft goods (textiles) and plastic parts design, manufacturing, and testing methods - Understanding of engineering change process with prior experience in creating engineering change notices or orders, conducting design or change reviews, and implementing them - Competency in statistics, process capability, design of experiments, including statistical applications such as Minitab - Experience in working with regulated industries like Medical devices, Aerospace, Automotive, etc. - Highly developed problem-solving skills with demonstrated successful resolution of project-level issues Role Overview: As an engineer in this role, you will be responsible for designing and developing mechanical components and systems in the medical device domain. You will work on multiple projects simultaneously in product engineering, including tasks such as gap assessments, design changes, manufacturing transfers, product development, and regulatory or business-driven projects. Your focus will be on deriving or remediating design requirements and engineering specifications that meet user needs. Additionally, you will be involved in creating or remediating technical documents such as Design History Files and Device Master Records. Key Responsibilities: - Design and develop mechanical components and systems in the medical device domain - Work on multiple projects simultaneously in product engineering - Derive or remediate design requirements and engineering specifications - Create or remediate technical documents including Design History Files and Device Master Records - Drive engineering changes through proper planning and analysis - Carry out engineering analysis through simulation, design of experiments, and engineering calculations - Liaise with lab team to carry out verification and validation activities - Collaborate with divisional partners to drive projects within schedule, cost, and quality baselines - Involve in technical discussions with stakeholders globally - Execute NC CAPA, implement design controls, and risk controls Qualifications Required: - Master's or Bachelor's degree in Engineering, Mechanical Engineering - Minimum of 3 years of work experience - Strong technical ability in creating engineering drawings and models, applying GD&T and CAE tools - Skilled in interpreting design, analyzing, and performing DFM, DFI, materials, and manufacturing - Ability to communicate moderate complexity plans and technical information to team members - Experience and knowledge of plastic films and film blown extrusion process preferred - Good working knowledge of CAD applications (Creo/SolidWorks/UniGraphics) - Experience with analysis tools, specifically tolerance analysis and FEA using ANSYS software preferred - Strong knowledge of soft goods (textiles) and plastic parts design, manufacturing,
