BACtrack | The Leader in Breathalyzers is hiring: Manufacturing Engineer in San

Every year, more than 10,000 people die in alcohol-related car crashes. At BACtrack, we are dedicated to providing tools that allow people to drink more responsibly. Our products save lives, and now we need YOUR help.

The Position

You will interface with our contract manufacturers to ensure our product specifications and quality processes are followed. You will maintain control of manufacturing and product related SOPs, and ensure complete product compliance with all international, and national regulations that are deemed necessary to allow for the import, export and sales of BACtrack products.

Core Responsibilities

Contract Manufacturing Management (35%) :  

• Communicate regularly with contract manufacturers to ensure BACtrack’s quality standards are maintained, production and product performance issues are resolved and process improvement is an ongoing priority.
• Travel to Asia 1 - 2 times per year to tour factories for a review of their processes and discuss process improvement.
• Coordinate factory audits as required by retail partners.
• Manage annual and periodic reviews of product BOMs for component cost control.
• Coordinate with Demand Planning, Purchasing, and Product Quality to ensure Corrective Action Report (CARs) are responded to and the appropriate improvements are implemented.

SOP and Product Specifications (35%)

• Maintain Bill of Materials (BOMs)
• Interpret our manufacturing processes for internal and external customers
• Coordinate with Contract manufacturers to ensure a complete and updated file of manufacturing SOPs.
• Understand and develop required FDA documents (ISO 13485) coordinating with product and engineering teams as needed.
• Design test fixtures and other equipment as needed to support the US based assembly, calibration and QC teams.
• Oversee development of final specifications
• Coordinate with the marketing, Logistics and Operations team to implement new products, product bundles.
• Assist with the development of internal processes to provide customized solutions for customers.

Product Compliance (30%)

• Coordinate with external engineering teams, marketing and sales to ensure products have the appropriate certification export, import and sale.
• Review existing certification to ensure continued compliance, initiate renewals as needed.
• Manage and maintain certification files.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field. 
• 5 - 7 years experience working in consumer electronics or medical device (Class 1) manufacturing environment 
• Experience with evaluating and improving manufacturing performance and effectively managing contract manufacturer relationships to drive process improvement, quality, and cost controls.
• Proficiency in CAD/CAM software (e.g., SolidWorks, AutoCAD), 3D Printing programs
• Ability to use Microsoft Excel fluidly to create and manipulate data analysis tools such as pivot tables.
• Desired experience with QMS systems – ISO 13485 compliant
• Strong analytical and problem-solving skills, with the ability to identify root causes of issues and implement effective solutions.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and influence stakeholders at all levels of the organization.
• Flexible and adaptable to changing priorities and business needs.

Why Consider BACtrack?

• We are a small, 27-person team that empowers its employees to take ownership of their work and make decisions that have real impact on the company.
• There is potential for career growth as the role and the company grow; we frequently promote from within.
• We design exciting products -- smartphone breathalyzers, wearable alcohol detectors and more, and your feedback will directly shape future products.
• BACtrack products are featured in national retailers like Best Buy and CVS and are often featured on TV and in publications.
• We offer medical, dental, vision, and retirement benefits.
• Our products save lives!

The ideal candidate is ready to roll up their sleeves and work hard, and will enjoy meeting the challenges of our fast-growing company.