Sr Process Development Engineer

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 115,000 colleagues serve people in more than 160 countries.

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

This position works out of our St Paul, MN location, in the Structural Heart (SH) Medical Device division. We are seeking an experienced, motivated, high caliber, Senior Process Development Engineer to join our engineering team.

This position will lead studies to develop and optimize processes to improve quality and manufacturability for delivery systems. The candidate should have a demonstrated record of implementing LEAN processes, working with R&D on specification assessments, new product introduction/development experience, working jointly with Quality for process and inspection improvements, working jointly with Regulatory on submission requirements and working with Finance to drive cost all while improving quality via RTG and CIP initiatives. You will have the unique opportunity to make a mark on the organization as a leader, while working on state-of-the-art product.

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.

What You’ll Work On

• Run design of experiments (DOE) studies to characterize processes to improve yield and efficiency.
• Coach, mentor, and provide guidance to other engineers, technicians, trainers, and sewing specialists.
• Manage projects which include new production equipment, process development/improvements and cost reductions while supporting new product introductions.
• Conduct process FMEAs and process validations.
• Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC).
• Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment.
• Work cross functionally with R&D, Finance, Quality and Operations to define process inputs and outputs.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s Degree in Chemical, Industrial, or Mechanical Engineering, or other related discipline.
• 5+ years manufacturing engineering experience in medical device or related industry, including working on and documenting process improvement initiatives.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Previous experience working in a highly matrixed and geographically diverse business environment.
• Strong analytical, problem solving, and project management skills.
• Strong organizational and follow-up skills, as well as attention to detail.
• Individual should be innovative, resourceful, and work with minimal direction
• Individual should have excellent organization, problem solving, communication, and team leadership skills.
• Proficient with MS Office (Word, Excel, Outlook, PowerPoint).
• Ability to travel approximately 10%, including internationally.

Preferred Qualifications

• Medical device experience.
• Previous close interface with R&D preferred.
• Previous surgical and/or transcatheter tissue heart valve experience in design and driving yield improvements, reducing cost, while increasing capacity.
• Lean 6 Sigma Green or Black Belt certification.

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

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.

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The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.]]><