Tandem Diabetes Care · 16 hours ago
Sr. Manufacturing Engineer I
Barnes, CA
Full-time
Hybrid
Mid, Senior Level
$109K/yr - $135K/yr
4+ years expTandem Diabetes Care creates innovative solutions for people living with diabetes. The Sr. Manufacturing Engineer I will provide technical leadership to the Manufacturing Engineering team, focusing on the manufacturing engineering aspects of a disposable inserter system and supporting new product introductions and process transitions to contract manufacturers.
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, drawings, inspection requirements, and metrics:
Manages and releases change orders
Manages design change assessments as applicable
Supports Manufacturing Engineering Management in applicable Metrics, such as cost, schedule adherence, yield, lot tracking, etc
Defines continual process improvement activities through review of metrics, Kaizen events, Lean Manufacturing, and/or Six Sigma designed to optimize process efficiency, reduce costs, and minimize line down time
Leads supplier development and qualification activities
Defines requirements for supplier manufacturing and test processes and assists in reviewing Supplier Capability
Supports identification of second sourcing opportunities
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 in the transition of new products and processes to manufacturing:
Leads the development of production test plans, requirements, and specifications
Partners with Quality to qualify equipment and/or processes as required
Leads Operations, Manufacturing, and Production leaders in Prototype Development Planning activities and pilot build activities
Supports Manufacturing Engineering in the transition of products and processes to CM:
Leads knowledge and document transfers
Confirms new processes/equipment at CM are equivalent in performance
Confirms new documentation at CM is accurate/equivalent in content
Assists in process validation 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
Qualification
Required
B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience
4-6 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
Ability to lead effective and efficient meetings with clear objectives and the necessary stakeholders
Experienced with MS Office and Minitab
Preferred
Lean Manufacturing and Six Sigma
Process design, development, test, and validation
Manufacturing within a clean room environment
Working with and supporting CM
Working with and supporting a global supply chain
Knowledge of SolidWorks software
Benefits
Competitive compensation package that includes bonus
Robust benefits package
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