Principal Mechanical Engineer

Abbott Laboratories Santa Clara, California
mechanical engineer design engineering devices mechanical technical lead regulatory regulatory requirements management healthcare people
March 21, 2023
Abbott Laboratories
Santa Clara, California
FULL_TIME

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.


Report this job

Similar jobs near me

Related articles