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.
About Abbott
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.
A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Sylmar, CA, currently has an opportunity for a Sr Process Engineer – Cardiac Implantable Medical Devices.
WHAT YOU’LL DO
We are seeking an experienced, high caliber Process Engineering technical expert to lead process development, validation and process control improvements of Cardiac Implantable Medical Devices.
A successful candidate will have expertise in medical device development, process improvement of device assembly and experienced in medical device manufacturing. The position will play a key role in planning and executing our Process Development and Operations strategy required to support new and legacy product approvals. This position will work across the organization driving and collaborating with functions in Development, Operation, Quality and Regulatory to assure the successful execution of our business goals.
Impact this role will have on Abbott:
Process Engineering:
- Process development, characterization and validation of cardiac implantable devices and sub-assemblies.
- Produce and review design drawings and specification documents.
- Equipment selection, tooling and fixture development, procurement, installation and qualification.
- Design, build, and execute testing of components or sub-assemblies; document and present test plans to broader audience
- Develop and validate test methods and inspection methods
- Understanding of medical device design controls; lead design reviews and ensure on-time completion of Design Control deliverables
- Prepare risk management files and identify mitigations; drive risk management activities from product conception through commercialization.
- Lead troubleshooting of process and equipment.
New Product Introduction:
- Lead design transfer to manufacturing, provide training to manufacturing operators and junior colleagues for process, product and equipment.
- 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 multiple transfers of new device assembly requirements to manufacturing with hands-on technical support: including developing Six Sigma processes/documentation for routine clinical and/or commercial production.
- Coordinate and manage multiple NPI programs, drive schedules and ensure deliverable are met
- Provide customer interface during the design, development and manufacture of the NPI products
- Manage Internal and External suppliers design, manufacturing and qualification activities.
Process Performance:
- 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 device manufacturing 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
- BS/ MS/Ph.D. in Mechanical Engineering, Biomedical Engineering, Chemical/Biochemical Engineering.
- Bachelor’s Degree with 7 + years of Process Engineering or Operations experience OR a Master’s Degree with 5+ years of Process Engineering OR Operations experience, Ph.D degree with 3+ years of Process Engineering or Operations experience.
- Process/equipment development and optimization experience for Class III medical devices
- 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. .
- Work history with cGMPs, regulatory filings and compliance issues for medical devices.
- Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.
- Solidworks/Creo or other CAD experience
WHAT WE OFFER
- At Abbott, you can have a good job that can grow into a great career. We offer:
- 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: www.abbottbenefits.com
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.