Senior Process Development Engineer

The Opportunity

Our St Paul, 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 Vascular business unit. This is a fully onsite role.

WhatYou’llWork 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 / Cpkand SPC, to analyze and improve processes,componentsand products.

Work with cross-functional teams including R&D, Quality, Operations, and Regulatory teams. Collaborate with R&D to ensure adherence toDesign forManufacturability (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 ensuretimelydelivery of program milestones.

Maintain communications with all levels of employees, customers, and vendors.

Comply withU.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, communication 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

Balloon catheter experience

Additional Qualifications :

• Beinnovative, 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

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.