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 Responibilities:

•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

•Assists on-time completion of Design Control Deliverables.

•Design and Evaluates mechanical and electromechanical product design and ability to identify potential design issues and drive technical decisions

 •Prepares risk management files and report 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 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 timely manner. Strong organizational and follow-up skills, as well as attention to detail. 

• Ability to travel including internationally.

• Proficient at predicting product performance with FEA

In specific locations, the pay range may vary from the range posted.