Business Title Mechanical Engineer II

Abbott; Sylmar (MD); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott in Sylmar is seeking a Mechanical or Biomedical Engineer to design and develop innovative medical devices or components. You will work on multidisciplinary teams, use CAD tools (SolidWorks/Creo), and contribute to risk management and regulatory compliance.

The role involves supporting pre-clinical and clinical testing, design reviews, and cross-functional collaboration with vendors. A strong engineering foundation and travel readiness are required.

Qualifications

• Bachelor's degree in mechanical/biomedical engineering or equivalent.
• Minimum 3 years designing and testing relevant medical devices preferred.
• Experience with CAD tools (SolidWorks/Creo) required; DFMEA/Design for Six Sigma experience preferred.

Responsibilities

• Design sub-assemblies to meet design goals and specifications.
• Conduct empirical, numerical and experimental analyses of designs.
• Develop test methods and models; mitigate sub-assembly risks.
• Support design reviews and on-time delivery of Design Control Deliverables.
• Ensure design quality, reliability and regulatory compliance.
• Collaborate with internal teams and vendors for prototypes and capabilities.
• Support pre-clinical and clinical testing of devices.
• Understand FDA/ISO requirements and manage project schedules.

Skills

Team collaboration

Verbal and written communication

Travel readiness

DFM and design review

Risk management awareness

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 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