Business Title Mechanical Engineer II

3205 St. Jude Medical, Cardiology Division, I; Los Angeles (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott in Sylmar, CA is seeking a multidisciplinary mechanical/biomedical engineer to design and develop medical devices and components. You will work on sub-assemblies, perform analyses, and support design validation in a fast-paced, regulated environment.

This role emphasizes design for Six Sigma, risk management, supplier interaction, and compliance with FDA/ISO standards. Travel up to international, and collaboration across teams to ensure timely completion of Design Control Deliverables.

Qualifications

• Bachelor's degree in mechanical/biomedical engineering or equivalent.
• Experience designing and testing medical devices is preferred.
• Solidworks/Creo CAD experience required.
• Analytical design and DFx (Six Sigma) knowledge preferred.

Responsibilities

• Design sub-assemblies to meet design goals and establish requirements.
• Conduct empirical, numerical, and experimental analyses of designs.
• Support design reviews and timely completion of design control deliverables.
• Identify and mitigate sub-assembly risks and contribute to risk management files.
• Coordinate with internal departments and vendors for prototypes and validation.
• Support pre-clinical/clinical testing and regulatory compliance activities.

Skills

Mechanical design

Biomedical engineering

DFM

CAD (SolidWorks/Creo)

FEA

Regulatory knowledge

Team collaboration

Travel ready

Education

Bachelor's Degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Creo

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION

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

The base pay for this position is $81,500.00 – $141,300.00 In specific locations, the pay range may vary from the range posted.

Job Family

Product Development

Division

CRM Cardiac Rhythm Management

Location

United States > Sylmar : 15900 Valley View Court

Additional Information

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Work in a clean room environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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