Process Development Mechanical Engineer II

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

We are seeking an experienced, high caliber Mechanical Engineer II to use multidisciplinary engineering knowledge to lead and contribute to a team designing and developing innovative mechanical medical devices or components/subsystems in support of company’s strategic plan. This engineer will be expected to apply their analytical and practical engineering principles in analyzing mechanical systems, overseeing the designing and running of tests, improving or fixing product features, and documenting findings. This individual should bring a level of enthusiasm, positive outlook, and inquisitiveness as they participate on cross-functional teams to resolve technical problems. The incumbent should have an affinity to learn and grow as they collaborate and support cross-functional team members from a wide range of Abbott departments in multiple geographic locations, as well as with suppliers and customers.  
 

The duties and responsibilities for this position include, but are not limited to, the following: 

• Ability to make critical judgments and decisions 
• Provide leadership on engineering projects
• Collaborate on sub-assembly process to meet broad process goals 
• Establish requirements and specifications 
• Use empirical, numerical and statistical analysis to analyze process and equipment 
• Perform Tolerance Analyses of complex assemblies 
• Define test methods and conduct testing of complex mechanical and electro-mechanical assemblies 
• Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations  
• Responsible for conducting Technical Reviews at various development stages 
• Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. 
• 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. 
• Performs other related duties and responsibilities, on occasion, as assigned. 
   

Experience and Education: 

• Bachelor’s degree in Mechanical Engineering or similar discipline
• 3+ years engineering experience in the Process Development function in the Medical Device industry 
• Proven ability to lead projects from inception to commercialization 
• Experience translating product needs to process requirements 
• Experience with Solid works and/or other CAD modeling software 
• Knowledge of medical device process development (ISO, GMP, FDA, CE) and process controls 
• Ability to travel approximately 10%, including internationally 

Preferred Qualifications and Education:  

• Experience in meeting product requirements through process controls
• Exposure to a variety of manufacturing processes and designing for manufacturability preferred 
• Experience working in a broader enterprise/cross-division business unit model preferred. 
• Familiarity with the interplay between process controls, dimensioning and tolerancing standards
• Exposure to a range of engineering areas that include electrical, polymeric materials, biology is desirable

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