Senior Process Development Engineer

Reposted 2 Days Ago
Be an Early Applicant
Minnetonka, MN
In-Office
75K-151K Annually
Senior level
Healthtech
The Role
Design and develop manufacturing processes, analyze and improve them using statistical methods, ensure compliance with FDA regulations, and mentor junior engineers.
Summary Generated by Built In
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:

Senior Process Development Engineer

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

Our Minnetonka, Minnesota location is seeking a high caliber, motivated, self-driven leader to join our Process Development engineering team for delivery catheter system development in Abbott’s Cardiac Rhythm Management (CRM) business unit.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

What You’ll Work On

  • Design and develop manufacturing processes, tooling, and fixtures to meet new product program schedules, enhancing product quality and taking into consideration problems inherent in the transfer of technology from research to manufacturing.
  • Utilize methodologies and statistical analyses, such as DMAIC, Gage R&R, Cp/Cpk and SPC, to analyze and improve processes, components and products.
  • Work with cross-functional teams including R&D, Quality, Operations, and Regulatory teams. Collaborate with R&D to ensure adherence to Design for Manufacturability (DFM) principles.
  • Understand principles of Cost of Goods Sold (COGS) including material, direct labor, and overhead costs as well as in consideration to manufacturing process yields.
  • Proficient in reading and creating engineering drawings, including dimensions, tolerances, and schematics. 
  • Drive process improvements and validations through manufacturing implementation and revise process failure mode effects analyses (pFMEAs).
  • Author and execute validation protocols and reports including installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and process performance qualifications (PPQ). 
  • Provide technical mentorship and direction for junior engineers and ensure timely delivery of program milestones.
  • Maintain communications with all levels of employees, customers, and vendors.
  • Comply with U.S. Food and Drug Administration (FDA) regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Requires understanding of compliance, pharmaceutical, pharmacological, biological, biochemical, medical, patent, and commercial factors.
  • May make recommendations concerning the acquisition and use of new technological equipment and materials.

Required Qualifications

  • Bachelor's degree in engineering field
  • 5+ years of related experience
  • Strong analytical, problem solving and project management skills
  • Demonstrated leadership capability in team settings
  • Ability to lead and motivate peers, drive change and problem solve with creativity.

Preferred Qualifications

  • Medical Device experience
  • Individual should:
    •  Be innovative, resourceful, and work with minimal direction
    •  Have excellent organization, problem solving, communication, and team leadership skills
    •  Have ability to multitask, priorities their work and make data driven decisions
    •    Work effectively with cross-functional teams    

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 safety is our priority
  • Production areas that are clean, well-lit and temperature-controlled
  • 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

     

The base pay for this position is

$75,300.00 – $150,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:Manufacturing

     

DIVISION:CRM Cardiac Rhythm Management

        

LOCATION:United States > Minnesota > Minnetonka : 14901 DeVeau Place

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:Not specified

     

MEDICAL SURVEILLANCE:No

     

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), Work in a clean room environment

     

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

Top Skills

Cp/Cpk
Dmaic
Gage R&R
Spc
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The Company
Abbot Park, IL
97,838 Employees

What We Do

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 109,000 colleagues serve people in more than 160 countries.

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