Abbott Senior Process Engineer (Injection Molding/Med Device) in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Process Engineering technical expert to lead development and commercialization of injection molded components and tools, drug product molding process development, validation and technology transfer in support of Medical Device combination products.
The position will play a key role in planning and executing our Development and Operations strategy required to support new product approvals and to meet legacy product regulatory commitments. 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:
Expertise in all aspects of plastics injection molding and liquid silicone molding technology in a regulated industry. Good understanding of thermoplastic and liquid silicone rubber materials and material selection process.
Experience with injection molding process development and process validations in medical device /Pharmaceutical industry; ability to trouble shoot technical issues related to injection molding process.
Experience with plastic part design for manufacturability concepts and with mold design and build processes.
Good understanding of (SPI) injection mold classifications.
Experience in interfacing with injection molding vendors and pharmaceutical equipment vendors.
Coordinate and lead commercial drug product manufacturing operations with technical evaluation of NCMR/CAPA, scale up, validation, and technology transfer. This includes drug product manufacturing (material preparation, mixing, molding, and inspection).
Lead regulatory filings and inspections.
Troubleshoot issues with drug product processing technologies and equipment.
New Product Introduction:
Provide process development expertise and training to manufacturing operators and junior colleagues for commercial drug product processing in specific areas such as injection molding, drug product molding, drug product manufacturing principles, reserve samples, sterile processing, process characterization, tech transfer and Validation.
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 legacy and 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 drug 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 and External suppliers design, manufacturing and qualification activities.
Good understanding of statistical tools such as DOE, process capability analysis, Gage R&R, etc.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
BS/ MS/Ph.D. in an engineering field such as plastic, polymer, Mechanical, Chemical, Biomedical Engineering or Chemical/Material Science.
Bachelor's Degree with 9 + years of Engineering or Operations experience OR a Master's Degree with 7+ years of Engineering OR Operations experience, Ph.D. degree with 5+ years of Engineering or Operations 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, drug product 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, PFMECA, DFMECA.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org