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.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Our location in Temecula, CA, currently has an opportunity for a Senior Manufacturing Process Engineer
Provides support to the manufacturing organization by developing new processes and optimizing existing processes. Utilizes six sigma, lean, design control, and validation principles to create robust processes. This role requires completion of steps from process conception, design, validation, and implementation to manufacturing. Interfaces with Manufacturing, Quality and Research and Development organizations to integrate new processes into the existing manufacturing areas.
WHAT YOU’LL DO
- Have polymer processing and manufacturing experience.
- Be responsible for multiple projects associated with manufacturing support, including process improvement, qualifying process equipment for new/existing products, and troubleshooting of polymer and assembly processes.
- Play a key role in planning and executing our Development and Operations strategy required to support product approvals and to meet legacy product regulatory commitments.
- Work across the organization driving and collaborating with functions in Development, Operation, Quality and Regulatory to assure the successful execution of our business goals.
Coordinate and lead commercial manufacturing operations with technical evaluation of NCMR/CAPA, scale up, validation, and personnel training development. This includes polymer processing and product manufacturing/assembly (material preparation, extrusion, and inspection). Troubleshoot issues with product assembly, polymer processing technologies, and equipment.
Support process development and provide training to manufacturing operators and junior colleagues for polymer and assembly processes.
Experience with the extrusion process and process validations in medical device /Pharmaceutical industry; ability to trouble shoot technical issues related to the extrusion process is a plus.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory agencies, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Coordinate and manage commercial manufacturing activities with hands-on technical support: including developing Six Sigma processes/documentation for commercial production.
Coordinate and manage multiple process improvement investigations, drive schedules and ensure deliverable are met
Interface with Product Development Engineering during the design, development, and manufacture of the NPI products
Projects involve leading collaborating with cross-functional teams developing test plans, leading root cause analysis and participating in investigations. Also making presentations to internal/external customers, vendors, and senior management
Develop, plan and track risk assessment for commercial product operations non conformances, change controls, and implements appropriate CAPAs. Lead process modelling, data trending and advanced statistical & process analysis – present data/metrics to teams.
Implement process improvement strategies to improve quality, reliability and/or reduce cost.
Manage Internal manufacturing and qualification activities.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelors Degree. Chemical/Biochemical Engineering, Polymer Engineering, Mechanical Engineering, Biomedical Engineering, or Science
- Minimum 7 years Bachelor's Degree with 7 + years of Process Engineering or Operations experience
- Minimum 5 years Master's Degree with 5+ years of Process Engineering
- Minimum 3 years Operations experience, Ph.D degree with 3+ years of Engineering or Operations experience.
- Process/equipment development and optimization experience.
- Experience in project management including the ability to manage multiple projects, strategically prioritize activities and leading cross functional teams within Operations/Manufacturing.
- Proven track record of successful collaboration and leadership to cross-functional teams to advance complex projects to completion. Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude.
- Process/equipment development and optimization experience with late stage or commercial products.
- Strong knowledge of Quality systems, manufacturing and validation.
- Work history with cGMPs, regulatory filings and compliance issues for combination devices.
- Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience.
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
Learn more about our benefits that add real value to your life to help you live fully: [ Link removed ] - Click here to apply to Senior Manufacturing Process Engineer
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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