Principal Mechanical Engineer
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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 113,000 colleagues serve people in more than 160 countries.
MAIN PURPOSE OF ROLE
This is a newly-created, full-time position. Will use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company's strategic plan. Provide site wide technical leadership in area of expertise.
MAIN RESPONSIBILITIES
Design Devices to meet user needs. Establish requirements and specifications for these devices (including justifications and supportive testing)
Establish site wide technical competence in specific areas.
Use empirical, numerical and experimental analysis to evaluate designs. Lead test method and model development. Develop site standards.
Identify and mitigate project and site product line risks.
Prepare and submit invention disclosures and steer investigations into promising areas
Work with internal departments and external vendors to obtain prototypes and to expand these groups capabilities
Lead Pre-clinical and clinical testing of devices
Lead design reviews and physician visits. Develop relationships with key physicians
Provide site technical leadership based on a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
Maintain a detailed understanding of the quality and regulatory requirements of SJM, FDA and ISO regulation. Provide input into shaping SJM quality and regulatory requirements
Work with Project management to develop 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.
Conducting mechanical and system investigations for root causes. Along with Conducting design enhancements for Design for Cost, Design for Reliability, and Design for manufacturability.
PREFERRED / OPTIONAL EDUCATION, EXPERIENCE, etc.:
Education: BS Mechanical Engineering (or mechatronics) with minimum of 8 (+) years of relevant experience
Job Description/Duties /Expectations:
Mechanical simulation and/or testing Software programing (Simulink, MATLAB, LabView, etc.)
Experience in creating and executing test protocols
Geometric Dimensioning and Tolerance experience (GD&T)
8+ years of CAD experience (Solidworks).
Proven success in troubleshooting, designing for Manufacturability, Cost, Service, and Reliability (Dfx)
Proven success in Mechanical system/electromechanics design
Electrical engineering experience
System level thinking in order to understand system/subsystem requirements, function, theory of design, to enable design optimizations and improvements.
Deep understanding of mechanical design fundamentals along with understanding of “how things work”
Ability to identify root cause of failures of complex subsystems and correct issues
Ability to communicate and work with cross functional team members
Hands on type of engineer.
Coach and mentoring of less experienced team members.
JOB REQUIREMENTS:
Bachelor’s Degree in Science, Technology, Engineering and Mathematics (STEM)
Experience/Background
Minimum 8 years of relevant experience in systems and/or software engineering
Recognized experience leading complex system and risk analysis.
Demonstrated ability to lead and utilize data to make decisions and influence
stakeholders.
Demonstrated success in technical proficiency, creativity, and independent
thought.
Excellent verbal and written communication skills.
Expert knowledge of Systems Engineering principles and concepts.
Demonstrated ability to apply principles of systems thinking to accelerate
performance.
Demonstrated Customer Focus, making their needs a primary focus of one's
actions.
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