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 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The position of Sr. Principal Mechanical Engineer is within our Rapid Diagnostics Infectious Disease business unit located on site in San Diego, California. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
This role is a recognized expert with broad expertise in mechanical design engineering, new product development and design transfer with responsibility for resolving significant technical issues as well as providing direction for new technology and product development activities with a broad impact to the company goals.
What You’ll Work On
Responsible for technical leadership of the Mechanical Design Engineering Group. Works on the design and development of significant new products. Key decision input in identifying of areas of technology for potential implementation into our products and processes. Leads the technical supervision and project management of complex engineering projects and activities. Develops networks involving cross-functional and cross departmental groups (Operations, Marketing, Quality, Regulatory) as well as communication to senior and executive management.
RESPONSIBILITIES:
- Technical leader responsible for providing mentoring and technical guidance to engineering staff.
- Specify, design, verify and validate new mechanical designs, in accordance with applicable medical regulatory standards.
- Responsible for the development of technical project plans and schedules covering all engineering activities, meeting all design control and product development SOP requirements.
- Responsible for the creation of project schedules and setting and maintaining budgets.
- Lead the development of product specifications, FMEAs, DOEs, verification and validation protocols and plans.
- Communicates effectively and participates on cross functional development teams.
- Participates in technical design reviews of mechanical design, hardware, PCBA interface, mechanical assemblies, production processes, product design and requirements documents.
- Act as independent reviewer on programs in which not directly involved.
- Ensures that product designs, components and materials meet all applicable standards Responsible for compliance with applicable Corporate and Divisional Policies. Responsible for utilizing and maintaining the effectiveness of the quality system.
- Development and execution of new medical devices, processes, equipment, materials, verification and validation. Implement approved Design Control procedures for product development in accordance with FDA guidelines.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
- Carries out duties in compliance with established business policies
- Other duties as assigned, according to the changing needs of the business
Required Qualifications
- Bachelors Degree (± 16 years) Mechanical Engineering or equivalent engineering or scientific discipline. Or an equivalent combination of education and work experience
- Minimum 10 years of related experience in engineering in a similar role.
Preferred Qualifications
- Masters Degree (± 18 years) Preferred.
- Experience in working in the Medical Device industry like Abbott or similar companies.
- Strong technical experience in mechanical engineering, with excellent written and verbal communication skills.
- Excellent knowledge of general engineering principles.
- Extensive knowledge of regulations for medical device development (ISO15197,
- ISO134851, ISO13485, FDA) desired.
- Extensive understanding of processes and materials used in the development and manufacturing of medical devices ideal.
- Extensive experience in all of the following: Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis;
- Working in a development environment with an emphasis on medical device product development; Writing product requirements and design specifications; Supporting equipment/facility/process commissioning and validation required; Working on a development team with an emphasis on minimizing time to market; Design formanufacture of low cost, high volume disposable products.
- Extensive knowledge and understanding of GxP, ISO and medical device regulations and the development and implementation of new products in a regulated environment desired.
- Extensive experience working in cross-functional team environments is required.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is
$128,000.00 – $256,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Product Development
DIVISION:
ID Infectious Disease
LOCATION:
United States > San Diego : 4545 Towne Center Court
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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
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