Sr. Mechanical Engineer

United States - California - Sylmarsenior

EngineeringMechanical Engineer

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Overview

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,

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EngineeringMechanical Engineer

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 115,000 colleagues serve people in more than 160 countries.

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Our location in Sylmar, CA, currently has an opportunity for a Sr. Mechanical Engineer.

Sr. Mechanical Engineer will design and develop innovative medical devices or components/subsystems in support of company's strategic plan.

Responsibilities

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Design medical devices to meet user needs.
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Establish requirements and specifications for these devices (including justification and supportive testing).
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Use experimental, empirical and numerical analysis to evaluate designs. Lead test method and model development. Create and own mechanical design drawings and models.
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Identify and mitigate project risks.
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Work with internal departments and external vendors to obtain prototype parts and to expand these groups’ capabilities.
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Lead pre-clinical and support clinical testing of devices.
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Lead design reviews and support physician visits.
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Maintains a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
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Maintain a detailed understanding of division, FDA and ISO regulation. Provide input into shaping division quality and regulatory requirements.
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Work with project management to develop overall schedule. Manage time and tasks within schedule.
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Make decisions on material usage including implant grade metals and polymers
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Work closely with outside vendors and manage complex projects with them
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Document and run design verification and validation testing which will be submitted to the FDA and other regulatory bodies
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Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
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Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
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Mentor junior engineering team members providing engineering and technical leadership.

Bachelors Degree in Mechanical Engineering or related or an equivalent combination of education and work experience.

Nice to Have

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Masters Degree in Mechanical Engineering or related field.
Class III medical device R&D experience
Cross functional team experience
Experience designing and testing electromechanical medical devices.
Proficient and experienced in medical device design controls, CAPA, production and process controls and risk management.
Wide variety of manufacturing processes and DFM experience
Solidworks/Creo or other CAD experience
Analytical design, Design for Six Sigma, or similar tool set experience

What We Offer

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At Abbott, you can have a good job that can grow into a great career. We offer:

✓Training and career development, with onboarding programs for new employees and tuition assistance

✓Financial security through competitive compensation, incentives and retirement plans

✓Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

✓Paid time off

✓401(k) retirement savings with a generous company match

✓The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Product Development

CRM Cardiac Rhythm Management

United States > Sylmar : 15900 Valley View Court

Standard

Yes, 5 % of the Time

Awkward/forceful/repetitive (arms above shoulder, bent wrists), 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