What are the responsibilities and job description for the Process Development Engineer II position at Abbott?
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, 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.
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 efficiencies
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
3 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
