Director, Internal Quality

Biofire • Broomfield, CO

17d • $185,000 - $225,000 • Onsite

About The Position

As Biofire’s Head of Internal Quality, you’ll have broad responsibility over both production quality and manufacturing engineering. In your production quality role, you’ll ensure that every smartgun that leaves our Final Assembly Test and Packout (FATP) facility meets Biofire’s high performance standards, ensure that Make-to-Specification purchased parts and in-house subassemblies meet performance standards, lead root cause analyses and implement corrective actions to boost yield and production rates. In your manufacturing engineering role, you’ll lead efforts to scale our in-house manufacturing capabilities while continuously developing new processes to support design changes and New Product Introduction (NPI); you’ll develop and validate all manufacturing processes and design and modify line layouts to support increasing production volumes.
If you’re a seasoned production quality or manufacturing engineer leader with a strong track record of scaling production from Prototype to Volume Production and are excited about building a production organization from the ground up, we’d love to hear from you.

Requirements

• 10+ years of experience leading production quality and designing and developing manufacturing lines in automotive, consumer electronics or medical device manufacturing
• A proven track record of scaling something from the 10s of products per month to the 1000s of products per month
• 5+ years of direct leadership experience in manufacturing engineering or production quality
• Exceptional ability to keep multiple projects moving forward in parallel.
• Demonstrated CAD fluency
• Proven ability to solve challenging problems quickly and seamlessly
• Hands-on experience with factory layout design, process mapping, and line balancing
• Demonstrated core competencies - GD&T, PFMEA, Process Development and Implementation
• Experience with DFM/DFA principles and working closely with design engineers
• Understanding of Traditional & Non-Traditional Manufacturing & Assembly Processes such as Injection Molding, Stamping, Die Casting, 3D Printing, Fastening, Welding, Adhesive Joining, etc
• Excellent communication - written, verbal, and visual. You know how to tailor to your audience with the right level of technical depth
• Comfortable with volatile, uncertain, complex and ambiguous environments

Responsibilities

• Lead and develop a high-performing team of manufacturing engineers, quality engineers and IQC / OQC technicians. Set a clear vision, define ambitious goals, and foster a culture of accountability, innovation, and technical excellence
• Cultivate a performance-driven team culture that emphasizes a data-based decision making, bias for considered action, simplicity, and the pursuit of reliable, scalable manufacturing processes
• Drive increases in product quality by implementing repeatable processes and meeting self-defined quality standards (FPY, SPY, Cpk)
• Own the end-to-end development of manufacturing capabilities, including planning, budgeting, designing, procuring, commissioning, and validating in-house assembly lines and associated equipment
• Define and implement manufacturing process and quality documentation, including process flows, PFMEAs, standard work instructions, setup checklists, training plans, and control plans
• Partner with Engineering teams to identify and drive design-for-manufacturability improvements that simplify assembly, improve product quality, and reduce cost
• Provide expert technical support to Production teams, leading root cause analysis and implementing corrective actions for production issues
• Establish and monitor key performance indicators (KPIs) for cost, quality, and delivery—including first-pass yield, cycle time, cost of poor quality, and on-time delivery. Analyze quality data and KPIs to identify trends, generate insights, and implement process improvements
• Define and document inspection plans, acceptance criteria, and rework procedures for common failures in mechanical, electrical, and composite systems
• Collaborate with Supplier Quality Engineering / Supplier Industrialization Engineering to provide actionable feedback, qualify new vendors, and improve incoming part quality
• Drive continuous improvement initiatives across Biofire’s FATP lines - Production, IQC and OQC -exploring automation, vision systems, and other innovations to eliminate waste, reduce variability, and increase throughput
• Own capital planning and resource allocation for new production lines and facility upgrades to support increasing production demand and NPI
• Develop ramp-up strategies and scalability plans to support production growth—from low-rate initial builds to full-rate manufacturing and global deployment
• Collaborate cross-functionally with Engineering, Finance, Production and Supply Chain to ensure alignment and execution across all phases of product lifecycle

Benefits

• Stock Options in Biofire, 401(k), HSA - and other financial benefits
• Medical Insurance - including plan options with $0 payroll deduction
• Dental, Vision and Life Insurance Plans - with $0 payroll deduction
• 3 Weeks Vacation and Sick time (Flex Time for salary positions), and 13 Paid Holidays
• Parental Leave - and other family-building, adoption and surrogacy benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed
• Number of Employees: 11-50 employees