Sr. Design Engineer/Staff Engineer

Role Overview: As an engineer in our team, you will be responsible for designing and developing mechanical components and systems in the medical device domain. You will work on multiple projects simultaneously, ensuring gap assessments, design changes, manufacturing transfers, product development, regulatory or business-driven projects, etc. Your role will involve deriving or remediating design requirements/engineering specifications, creating or remediating technical documents, driving engineering changes, and collaborating with various stakeholders to ensure safe and robust solutions are delivered. Key Responsibilities: - Design & develop mechanical components & systems in the medical device domain - Work on multiple projects simultaneously in product engineering - Derive or remediate design requirements/engineering specifications - Create or remediate technical documents including drawings, labeling, packaging, instruction for use, etc. - Drive engineering changes through proper planning & analysis - Conduct engineering analysis through simulation, design of experiments, statistics, engineering calculations, etc. - Liaise with lab team to carry out verification and validation activities - Collaborate with divisional partners to drive projects within schedule, cost & quality baselines - Engage in technical discussions with stakeholders globally - Execute NC CAPA, implement design controls & risk controls Qualifications Required: - Master/Bachelors in Engineering, Mechanical Engineering - 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 - Experience & 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 and experience in creating engineering change notices or orders - 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. Understanding of medical device standards and regulations is preferred - Highly developed problem-solving skills with demonstrated successful resolution of project-level issues,