Responsible for developing new medical devices. Works on mechanical engineering problems of diverse scope. Exercises judgment and de?nes methods and criteria in conducting mechanical engineering experiments and DV - Ts and reports results. Develops networks with internal/external working relationships in area of expertise. MAIN RESPONSIBILITIES - Specify, design, verify and validate new medical devices, in accordance with applicable medical regulatory standards. Mechanical engineering support fo...
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 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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
We are currently looking for a Senior Mechanical Engineer for our Alameda, CA facility.
THIS IS AN ON-SITE DAILY POSITION
The Opportunity
This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.
MAIN PURPOSE OF ROLE
Responsible for developing new medical devices. Works on mechanical engineering problems of diverse scope. Exercises judgment and de?nes methods and criteria in conducting mechanical engineering experiments and DVTs and reports results. Develops networks with internal/external working relationships in area of expertise.
MAIN RESPONSIBILITIES
- Specify, design, verify and validate new medical devices, in accordance with applicable medical regulatory standards. Mechanical engineering support for on market product investigations and design improvements.
- Develops product speci?cations, conduct FMEAs, DOEs, veri?cation and validation protocols and reports and other associated documentation following design control requirements.
- Communicate effectively and participate on cross functional development teams.
- Conduct or participate in technical design reviews for product design and requirements documents. Write and submit Engineering Changes, as required.
- Responsible for utilizing and maintaining the effectiveness of the quality system. Responsible for compliance with applicable Corporate and Divisional Policies.
- Development and execution of new medical devices, processes, equipment, materials, veri?cation and validation Implement approved Design Control procedures for development in accordance with FDA guidelines.
Education Required:
Bachelors Degree (Mechanical Engineering or equivalent engineering or scienti?c discipline) AND 8+ years related work experience. Masters Degree) - Preferred
Experience Required:
- Solid knowledge of general engineering principles.
- Good knowledge of design controls and regulations for medical device development, (ISO15197, ISO134851, ISO13485, FDA). Strong technical experience in mechanical engineering with excellent written and verbal communication skills is essential.
- Strong understanding of processes and materials used in the development and manufacturing of medical devices.
- Experience in all of the following: Performing complex engineering calculations and relating results to controlled tests, including statistical analysis and tolerance analysis.
- Working in a development environment with an emphasis on new medical device development. Writing product requirements and design speci?cations.
- Working on a development team with an emphasis on minimizing time to market.
- Design for manufacture of low cost, high volume electronic products. Development of products in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.
- Working in cross functional team environments.
Additional Job Requirements:
- High volume medical devices or high-volume complex consumer product design experience desired such as in hard disk drives.
- Design, build and test prototypes to evaluate mechanical product design and ability to identify potential design challenges.
- Develop and validate test ?xtures, test methods, and inspection methods.
- Independently create test methods and execute testing to verify new designs and/or changes to existing designs.
- Present test plans to broader audience.
- Minimum 5 years’ experience working with Solid Works
- Sound fundamentals in Solid mechanics and strength of materials
- Prior experience with Tolerance analysis and GDT highly desirable.
- Produce and review design drawings and speci?cation documents.
- Prior experience with Injection Molded Plastics design is highly desirable.
- Work closely with outside vendors and manage projects of varying complexity with them.
- Document and run design veri?cation and validation testing which will be submitted to the FDA and other regulatory bodies.
- Use statistical techniques to facilitate decision making and to draw conclusions from available data.
- Ability to conduct a formal root cause investigation to identify potential design issues and provide input on solutions.
Apply Now
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- A fast-paced work environment where your contribution is essential to success
- 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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbottand on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is
$109,300.00 – $218,500.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Engineering
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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