Business Title Mechanical Engineer II

Main Role

Use multidisciplinary engineering knowledge to contribute to a team designing and developing innovative medical devices or components/subsystems in support of company's strategic plan.

Main Responsibilities

• Design sub-assemblies to meet broad design goals, establish requirements and specification
• Use empirical, numerical and experimental analysis to analyze designs
• Involved in test method and model development
• Identify and mitigate sub-assembly risks
• Support invention disclosures
• Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations
• Support pre-clinical and clinical testing of devices
• Support design reviews, assists on-time completion of Design Control Deliverables, and physician visits
• Drives design quality, reliability, and compliance to standards and regulations
• Design and evaluate mechanical and electromechanical product design and ability to identify potential design issues and drive technical decisions
• Prepares risk management files and reports for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization
• Supports design test and inspection method development
• Gain a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.)
• Gain a detailed understanding of the quality and regulatory requirements of Abbott, FDA and ISO regulations, manage project within these requirements
• Gain a detailed understanding of overall schedule, manage time and task within schedule
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Education

Bachelors Degree (± 16 years). Mechanical or Biomedical engineering or an equivalent combination of education and work experience.

Experience

• Minimum 3 years
• Experience designing and testing relevant medical devices preferred. Experience with a wide variety of manufacturing processes and DFM preferred
• Solidworks/Creo or other CAD experience required. Analytical design, Design for Six Sigma, or similar tool set preferred
• Ability to work within a team and as an individual contributor in a fast paced changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in a timely manner
• Strong organizational and follow-up skills, as well as an attention to detail
• Experience working in a broader enterprise/cross-division business unit model preferred
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to travel including internationally
• Proficient at predicting product performance with FEA