Tandem Diabetes Care ยท 19 hours ago
Sr. Manufacturing Engineer
Barnes, CA
Full-time
Onsite
Mid, Senior Level
$109K/yr - $136K/yr
4+ years expTandem Diabetes Care creates innovative solutions for diabetes management and is seeking a Senior Manufacturing Engineer to provide technical leadership to the Manufacturing Engineering team. The role involves overseeing manufacturing engineering activities, supporting new product introductions, and driving process improvements to enhance product manufacturability.
Medical Device
No H1B
Responsibilities
Supports the technical development of automated and manual assembly techniques, tooling, and identifies electro/mechanical testing development to improve product manufacturability
Supports operations with the creation/routing of BOMs, DHRs, Part Numbers, work instructions, and metrics:
Develops and updates work instructions and bill of materials
Manages and releases change orders
Supports Manufacturing Engineering Management in applicable Metrics, such as cost, schedule adherence, yield, etc
Defines continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead-times
Leads supplier development and qualification activities
Defines requirements for supplier manufacturing and test processes and assists in reviewing Supplier Capability
Provides training to manufacturing personnel on procedure, process, and equipment changes
Working with the Quality and R&D groups, leads root cause failure investigations, and develops and implements corrective and preventive action, as required
Tools include PFMECA, FMECA, DOE, Fault Tree analysis
Supports R&D and Design Engineering to aid in the transition of new products and processes to manufacturing:
Leads the development of production test plans, requirements, and specifications
Leads Operations, Manufacturing and Production leaders in Prototype Development Planning activities and pilot build activities
Confirms completion of required training plan before assuming job responsibilities
Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements
Other responsibilities as assigned
Qualification
Required
B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience
4 years of experience in medical device manufacturing
Experience in an FDA/GMP/ISO environment
Awareness of federal and other regulations, e.g. QSRs, ISO 14971 IEC 60601 series
Knowledge of Good Documentation Practices (GDP)
Good analytical and organizational skills with the ability to prioritize workload
Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
Skilled at creating a cooperative team environment
Ability to objectively evaluate situations and make recommendations for changes in light of overall project demands
Experienced with MS Office, knowledge of Solidworks software desirable
Preferred
Lean Manufacturing and 6 sigma experience
Experience in process design, development, test, and validation
Benefits
Health care benefits such as medical, dental, vision available your first day
Health savings accounts
Flexible saving accounts
11 paid holidays per year
A minimum of 20 days of paid time off (with accrual starting on day 1)
Access to a 401k plan with company match
Employee Stock Purchase plan
Company
Tandem Diabetes Care
Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
David Berger
EVP and Chief Operating Officer
Brian Hansen
Executive Vice President and Chief Commercial Officer
Recent News
The Motley Fool
2024-02-23
Medical Product Outsourcing
2024-02-02
Company data provided by crunchbase