Abbott

Principal Mechanical Engineer

Abbott • $130K — $261K *
Alameda, CA 94501In-Person
Healthcare
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in mechanical engineering or related field; Master's preferred.
  • 10+ years of experience in engineering.
  • Strong mechanical engineering technical experience with excellent communication skills.
  • Deep knowledge of engineering principles and medical device regulations (ISO and FDA).
  • Solid understanding of medical device development processes and materials.

Responsibilities

  • Specify and validate new mechanical designs compliant with medical regulations.
  • Support investigations into manufacturing line issues.
  • Develop and manage technical project plans, schedules, and budgets.
  • Lead teams in creating product specifications, FMEAs, and validation protocols.
  • Manage resources, project schedules, and budgets effectively.
  • Communicate and collaborate in cross-functional development teams.
  • Conduct technical design reviews and ensure compliance with quality systems.

Benefits

  • Opportunity to work on high-impact medical device projects.
  • Engagement in cross-functional collaboration and leadership.
  • Mentorship opportunities within a dynamic engineering team.
  • Exposure to cutting-edge technology and product development activities.
Full Job Description
JOB DESCRIPTION:

The Opportunity:

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. Works on the design and development of significant new products. Key decision-maker in identifying 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.

What you will do:
  • Specify, design, verify and validate new mechanical designs, in accordance with applicable medical regulatory standards.
  • Support high-level technical investigation of manufacturing line issues.
  • Responsible for the development of technical project plans and schedules covering all engineering activities, meeting all design control and product development SOP requirements
  • Works in the development and management of resource plans, budgets, schedules, etc.
  • Lead the development of product specifications, FMEAs, DOEs, verification and validation protocols and plans.
  • Responsible for managing resources, the creation of project schedules and setting and maintaining budgets.
  • Communicates effectively and participates in cross functional development teams.
  • Participates in technical design reviews of mechanical design, hardware, PCBA interface, mechanical assemblies, production processes, product design and requirements documents.
  • Writing, submittal, and approval of Engineering Changes, as required.
  • May review and approve ECs.
  • Act as independent reviewer on programs in which not directly involved.
  • Responsible for utilizing and maintaining the effectiveness of the quality system.
  • Ensure that product designs, components and materials meet all applicable standards
  • Responsible for compliance with applicable Corporate and Divisional Policies.
  • 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.
  • Provide mentoring, technical guidance for mechanical engineering team.

Required Qualifications:
  • Bachelor's degree in mechanical engineering or equivalent engineering or scientific discipline. Master's degree is preferred.
  • Minimum 10 years related experience in engineering.
  • 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 is ideal.

Preferred Qualifications:
  • 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 for manufacture 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.


The base pay for this position is
$130,700.00 - $261,300.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Product Development

DIVISION:
ADC Diabetes Care

LOCATION:
United States > Alameda : 1360-1380 South Loop Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 20 % 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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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