Abbott · 2 months ago
Senior Process Development Engineer
St Paul, MN
Full-time
Onsite
Mid, Senior Level
$78K/yr - $156K/yr
5+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The role involves designing and developing manufacturing processes for delivery catheter systems, improving product quality, and collaborating with cross-functional teams.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
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
Qualification
Required
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
Medical Device experience
Balloon catheter experience
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
Benefits
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
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
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