Sr. Mechanical Engineer

Abbott (abbottcareers2 board); United States; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Training & career development

Competitive compensation

Health and wellness programs

Paid time off

401(k) retirement plan

Job summary

Abbott is seeking a Senior Mechanical Engineer in Sylmar, CA to design and develop innovative medical devices or components. You will establish device requirements, perform analysis, and lead testing and design verification to support FDA/ISO regulatory submissions.

You will work with cross-functional teams and external vendors, lead reviews, mentor junior engineers, and ensure manufacturability and regulatory compliance throughout the product lifecycle.

Qualifications

• Bachelors 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 in a fast-paced environment.
• Strong verbal and written communications at multiple levels in the organization.
• Exposure to Six Sigma, analytical design.
• Experience with 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 with justification and testing.
• Use experimental, empirical and numerical analysis to evaluate designs; lead test methods and model development.
• Work with internal departments and external vendors to obtain prototype parts and expand capabilities.
• Lead pre-clinical and support clinical testing of devices.
• Lead design reviews and support physician visits.
• Maintain knowledge of clinical environment, regulations (FDA/ISO) and quality/regulatory requirements.
• Mentor junior engineering team members providing engineering and technical leadership.

Skills

Design for manufacturability

Six Sigma

Analytical design

Cross-functional collaboration

Verbal & written communication

Team leadership

Education

Bachelors Degree in Mechanical Engineering

Tools

Solidworks/Creo

CAD tools

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

• 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

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