Sr. Mechanical Engineer

Thornton Tomasetti; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Training & career development

Financial security

Health care & well-being

Paid time off

401(k) retirement plan

Company stability

Job summary

Abbott in Sylmar, CA seeks a Sr. Mechanical Engineer to design and develop innovative medical devices for cardiovascular rhythm management. You will lead design reviews, create drawings, and collaborate with vendors while ensuring compliance with FDA and ISO regulations.

The role requires 5+ years in design and testing of electromechanical medical devices, a Mechanical Engineering degree, and proficiency with CAD tools such as SolidWorks or Creo. Mentorship of junior engineers is expected.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• Minimum 5 years of experience designing and testing.
• Experience with a variety of manufacturing processes and designing for manufacturability.
• Ability to lead small teams and to work within large multi-discipline teams as an individual contributor in a fast-paced environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Exposure to latest design tools and techniques (six sigma, DFM, analytical design).
• Ability to work in a highly matrixed and geographically diverse business environment.
• Experience designing and testing electromechanical medical devices.
• Proficient and experienced in medical device design controls, CAPA, production and process controls and risk management.

Responsibilities

• Design medical devices to meet user needs.
• Establish requirements and specifications for these devices (including justification and supportive testing).
• Use experimental, empirical and numerical analysis to evaluate designs.
• Lead test method and model development.
• Create and own mechanical design drawings and models.
• Identify and mitigate project risks.
• Lead pre-clinical and support clinical testing of devices.
• Lead design reviews and support physician visits.

Skills

Mechanical design

Regulatory knowledge (FDA/ISO)

Project leadership

CAD (SolidWorks/Creo)

DFM / design for manufacturability

Analytical design

Cross-functional collaboration

Medical device R&D experience

Education

Bachelor's Degree in Mechanical Engineering

Masters Degree in Mechanical Engineering (preferred)

Tools

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

JOB DESCRIPTION: 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.

WHAT YOU’LL DO

• Design medical devices to meet user needs.
• Establish requirements and specifications for these devices (including justification and supportive testing).
• Use experimental, empirical and numerical analysis to evaluate designs.
• Lead test method and model development.
• Create and own mechanical design drawings and models.
• Identify and mitigate project risks.
• Work with internal departments and external vendors to obtain prototype parts and to expand these groups’ capabilities.
• Lead pre-clinical and support clinical testing of devices.
• Lead design reviews and support physician visits.
• Maintains a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
• Maintain a detailed understanding of division, FDA and ISO regulation.
• Provide input into shaping division quality and regulatory requirements.
• Work with project management to develop overall schedule.
• Manage time and tasks within schedule.
• Make decisions on material usage including implant grade metals and polymers.
• Work closely with outside vendors and manage complex projects with them.
• Document and run design verification and validation testing which will be submitted to the FDA and other regulatory bodies.
• 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.
• Mentor junior engineering team members providing engineering and technical leadership.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Required Bachelors Degree in Mechanical Engineering or related or an equivalent combination of education and work experience.
• Minimum 5 years of experience designing and testing.
• Experience with a variety of manufacturing processes and designing for manufacturability.
• Ability to lead small teams and to work within large multi-discipline teams as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Exposure to latest design tools and techniques (six sigma, DFM, analytical design).
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to leverage and/or engage others to accomplish projects.
• Preferred 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

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

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

The base pay for this position is $90,000.00 – $180,000.00. 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: 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 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.