Manager, Manufacturing Engineering

Tandem Diabetes Care•Ruth, CA

1d•$142,000 - $177,000•Hybrid

About The Position

Provides leadership and direction for Manufacturing Engineering. Responsible for all aspects of manufacturing engineering of infusion sets. Contributes to both sustaining and new development efforts, including all aspects of new product introduction. Responsible for manufacturing development planning and execution for prototype, pilot, and production design transfer. Responsible for defining, managing, and reducing product costs throughout the life cycle of the product. Supervises a team of engineers and technicians in support of supplier, process, process automation, failure analysis, and manufacturing engineering.

Requirements

Solid knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs).
Proficient with MS Office and knowledgeable of Solidworks software.
Ability to effectively use Microsoft Word, Excel, and PowerPoint for effective management reporting and presentation.
Proficient in understanding product specifications, test specifications, process specifications.
Proven ability to drive quality and productivity improvements.
Advanced integration experience in a manufacturing environment, to assist with the transfer of testing methodology to manufacturing.
Excellent skills in cGMP documentation, writing policies and procedures, protocols, work instructions, inspection requirements, etc.
Capable of managing multiple priorities effectively and be able to identify and recommend best course of action from several alternatives.
Ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
Able to gain cooperation of others.
Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
Able to make and prioritize process and resource decisions based on overall team needs.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
8 years experience in medical device manufacturing.
3 years experience managing/leading manufacturing engineering staff.
Experience in an FDA/GMP/ISO environment.
Lean Manufacturing and 6 sigma experience.
Project Management experience.

Responsibilities

Develops and defines automated and manual assembly techniques, tooling, and contributes to electro/mechanical testing development to improve product manufacturability.
Directs troubleshooting on systems that either cause or potentially cause work stoppage and reduced throughput times.
Designs and/or debugs manufacturing test fixtures for subassemblies and trains manufacturing staff on use.
Supports operations with the creation of BOMs, DMRs, DHFs, (e)DHRs, work orders, work instructions, test methods, product costs, and metrics.
Creates and measures applicable Metrics, such as cost, schedule adherence, yield, etc.
Responsible for meeting product cost targets and defining and implementing product cost activities.
Initiates and implements continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead-times.
Leads teams in the implementation of Lean Manufacturing and 6 sigma techniques.
Participates in Sustaining Engineering activities, including design improvements in support of improved manufacturing and testing of company’s products.
Reviews Process Capability Analysis (CPk).
Develops equipment and process requirements and/or validation protocols/reports.
Responsible for DOE, IQ OQ PQs, including writing and executing protocols.
Specifies and/or validates test processes and equipment to be used by external suppliers and assists in reviewing Supplier Capability.
Provides training and leadership to manufacturing personnel on procedure, process, and equipment changes.
Works with the Quality and R&D groups, determines root cause through failure investigation, and develops and implements corrective and preventive action, as required.
Works closely with R&D and Design Engineering to aid in the transition of new products and processes to manufacturing.
Helps develop production test plans, requirements and specifications.
Assists Operations, Manufacturing and Production leaders in Prototype Development Planning activities and pilot build activities.
Works closely with Contract Manufacturer(s) to aid in: Transition of new or existing processes/products. Sustained production of new or existing processes/products.
Analyzes and assesses vendor capability to support development and/or high-volume manufacturing.
Participates in the selection, development, performance appraisal, merit recommendation, and promotion of department staff.