Manager, Manufacturing Engineering

About the role

Provides leadership and direction for Manufacturing Engineering. Responsible for all aspects of manufacturing engineering of infusion sets. Manages a team of engineers and technicians in support of supplier, process, process automation, failure analysis, and manufacturing engineering.

Responsibilities

• Contributes to both sustaining and new development efforts, including all aspects of new product introduction.
• Defines, manages, and reduces 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.
• 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.
• Meets product cost targets and defines and implements 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.
• Ledges teams in the implementation of Lean Manufacturing and 6 sigma techniques.
• Leads sustaining engineering activities, including design improvements in support of improved manufacturing and testing of company’s products.
• Reviews Process Capability Analysis (CPk).
• Specifies and/or validates test processes and equipment to be used by external suppliers and assists in reviewing Supplier Capability.
• 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.
• Manages multiple priorities effectively and be able to identify and recommend best course of action from several alternatives.
• Able to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
• Able to effectively communicate department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
• Able to make and prioritize process and resource decisions based on overall team needs.
• 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.
• 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.

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.
• 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.
• Competent in understanding product specifications, test specifications, process specifications.
• Capable of managing multiple priorities effectively and be able to identify and recommend best course of action from several alternatives.
• Able to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
• Able to effectively communicate department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• 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.

Qualifications

• Extra Awesome

Skills

• Quality System Regulations (QSRs/GMPs)
• MS Office
• Microsoft Word, Excel, PowerPoint
• Product Specifications, Test Specifications, Process Specifications
• Quality and Productivity Improvements
• Manufacturing Integration
• MS Office
• MS Solidworks
• MS Word, Excel, PowerPoint
• Product Specifications, Test Specifications, Process Specifications
• Quality and Productivity Improvements
• Manufacturing Integration
• Lean Manufacturing
• 6 sigma
• Project Management

Benefits

• Compensation Range: $142,000 - $177,000 annually
• Benefits Package: Health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1), 401k plan with company match, and an Employee Stock Purchase plan.

Pay

The starting base pay range for this position is $142,000 - $177,000 annually.

Schedule

Hybrid: This role will be a mix of in-office work at our Barnes facility in San Diego, CA or Irvine, CA location and remote work. This position is expected to be in office 2-3 days per week but may vary depending on business demands.

Application Instructions

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

Why You’ll Love Working Here

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation.