Abbott

Sr Process Development Engineer

Abbott • $90K — $180K *
Santa Clara, CA 95051In-Person
Manufacturing & Automotive
5 - 7 years of experience
Reposted 1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Engineering (± 16 years).
  • Minimum 5 years experience in process engineering.
  • Experience in catheter assembly and process validations required.
  • Knowledge of US and international regulations.
  • Proficiency in Solidworks and statistical analysis skills.

Responsibilities

  • Oversee line output, safety, yield, and quality metrics.
  • Collaborate with cross-functional teams to resolve line issues and implement corrective actions.
  • Lead root cause analysis and continuous improvement projects using DMAIC principles.
  • Model and draft assemblies and tools using Solidworks.
  • Facilitate training programs for technicians and supervisors.

Benefits

  • Career development opportunities within an international company.
  • Eligibility for free medical coverage through the Health Investment Plan (HIP).
  • Generous retirement savings plan with high employer contributions.
  • Tuition reimbursement and support for student debt.
  • Recognized as a top employer for diversity and work environment.
Full Job Description
JOB DESCRIPTION:

The Opportunity

This position works out of our Santa Clara, CA location in the SH division.

Structural Heart Business Mission: Why We Exist.

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

As the Sr Process Development Engineer, you will serve as the primary engineering personnel supporting manufacturing operations. The individual performing this role will have strong collaboration with the line supervisor, Quality Engineer and operators to address all the opportunities found in the assigned manufacturing line. This role will be accountable on quality, output and yield of the assigned manufacturing line. Will also serve as the engineering management representative in the manufacturing line, executing initiatives and working directly with the DL workforce. This person may also have a role beyond the line support engineering as a sustaining engineer for the department. As a Senior Engineer, this person is one of the most experienced and expected to be subject matter expert in the site products and process.

What You'll Work On
  • Responsible for assigned line output, safety, yield and quality. Responsible for identification of product defects and determination of operational and process related actions to reduce the defects. This may also include equipment trouble-shooting and sub-sequent work order request.
  • Works with line support team (QC supervisor, Mfg. Supervisor, Quality Engineer and Operations) to perform on line issue triage to evaluate issues and determine if non-conformance is present, determine initial bracketing and containment, and generate corrective actions/preventative actions as needed.
  • Responsible for product/process knowledge and understanding of basic cause and effect of line changes. Considered and expert in statistics, product and Engineering process.
  • Responsible for modeling/drafting assemblies; fixtures & tools; Solidworks mid to advance level.
  • Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and manufacturing aids (from idea definition to implementation). Knowledgeable of procedures related to equipment controls.
  • Support technicians and supervisors in equipment availability issues.
  • Supports Training and Certification Program. Provides additional insight on how to improve trainings and certifications in the best interest of the business.
  • Responsible for determining quality impact of Out-of-Tolerance documents.
  • Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO and CR generation related to moderate to complex changes impacting the manufacturing line.
  • Responsible for continuous improvement projects development and execution, including CAPAs implementations. Responsible for exception subtask execution.
  • Evaluates ideas for continuous improvements.
  • Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s. Leads CAPA (Major) investigations with data gathering and analysis as needed. Owns CAPA activities without oversight.
  • Runs studies and validations on the line as needed.
  • Be the ME representative for manufacturing related projects including yield, CIP's, productivity, quality and safety.
  • Responsible for coordination of product builds through the NPI process.
  • Generates all types of changes to the eLHR system.
  • Leads ME support during external and internal audits.
  • Acts as coach and mentor to more inexperienced engineers or technical personnel.
  • Leads statistical analysis for complex events at the site.
  • Can generate qualification and validation protocols and reports with minimal oversight.
  • Owns basic to medium to high complexity CR activities with no oversight.
  • Demonstrates comprehensive understanding of regulations in area of work and where to look for information. Considered SME for most Engineering matters.
  • In conjunction with RA:
    - Understands regulatory implications of proposed changes.
    - Understands what types of changes require filings. Completes documentation to support regulatory filings with oversight.
  • Minimal oversight required for problems or assignments of reasonable difficulty. Makes decision in an efficient manner, even when having limited information.
  • Considers risk mitigation in planning based on lessons learned or from peers. Reviews previous similar projects and activities as part of the decision-making process. Anticipates potential situations that may impact projects timeline and resolves them before they become an issue.
  • Prepares and provides well thought out contribution to meetings. Provides technical guidance to peers that facilitates the progression of the project, group or person.
  • Can present information and collaborates with peers across functions (both internally and externally). Exposure to cross functional mgmt. communications.
  • Leads manufacturing engineering projects of high complexity, including CIPs, CAPA, Validations.
  • May have delegation authority for area manager.


Required Qualifications
  • Bachelors Degree (± 16 years) in Engineering related field.
  • Minimum 5 years experience.
  • Basic knowledge of applicable US non-US applicable regulations.
  • Knowledge and proficiency in the application and principles of Manufacturing/Process Engineering.
  • Ability to effectively communicate cross-functionally to assist with resolving Quality/Engineering issues.
  • Catheter assembly experience is required.
  • Process Validations experience is required.
  • Excellent written, verbal and interpersonal communication skills
  • Ability to interact effectively with all levels of employees.
  • Knowledge of common office applications: Word, PowerPoint, Excel.
  • Knowledge of statistical analysis.
  • 3-D drawing (Solidworks required).


Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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:
Engineering

DIVISION:
SH Structural Heart

LOCATION:
United States > Santa Clara : Building A - SC

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
No

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)

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.

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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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