Manufacturing Manager - Onsite

Who We Are

RefleXion elevates radiopharmaceuticals from drugs that help identify cancer to guides that actively direct external beam radiotherapy by leveraging tumor biology. Designated an FDA Breakthrough Device for lung tumors, RefleXion's SCINTIX biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. FDA-cleared SCINTIX therapy automates targeting and motion management for use in FDG-guided treatment of lung and bone tumors that arise from primary lung and bone cancers or are metastases from other primary cancers. In strategic collaborations with industry-leading radiopharmaceutical companies, RefleXion is co-developing and co-commercializing disease-specific radiotracers for treating late-stage cancers.

Find out more about RefleXion and SCINTIX therapy at reflexion.com.

Stay up to date with RefleXion by following our channels here:

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About This Role

The Manufacturing Manager will lead a team responsible for implementing best-in-class product manufacturing, assembly and test for RefleXion's groundbreaking radiotherapy devices. This Manufacturing team will work closely with NPI and Quality to build product in pilot and routine production. The Manufacturing Manager will ramp a new factory to meet aggressive build plans for the introduction of a new product. This role is also responsible for ensuring production staff and manufacturing tools are capable to meet Company objectives for product quality, delivery and cost. The successful candidate will be a strong functional leader with proven experience applying Lean manufacturing and continuous improvement practices, as well as medical device quality system compliance, to complex electromechanical capital equipment. This role will serve as the primary manufacturing manager for the factory and will be an evolving position in an exciting start-up company environment.

What You Will Be Doing

• Drive a culture change from development centered manufacturing systems to low-volume, high-mix production manufacturing

• Lead, hire, train, motivate, and make performance corrections for (10+) technicians and production leads

• Execute and maintain production schedules aligned with the company sales and operations plan

• Ensure product quality and compliance to FDA & ISO regulations

• Attain operational goals for yield, efficiency, and delivery

• Ensure employee safety and compliance to applicable Federal, State and company safety regulations

• Drive efforts to continuously improve quality and costs using the principles of lean manufacturing and operational excellence: lean flow, takt time, standardization, kanban, 5S, cross-training, etc.

• Create, apply, and monitor performance metrics to personnel, products, and methods

• Recognize & solve problems affecting production including scheduling, staffing, quality, supply chain, EH&S, facilities and equipment

• Partner with R&D, QA, and Supply Chain to launch new products and improvements to the current product

• Other duties as assigned

Where You Will Do This Job

• Onsite

• This position requires the successful candidate to work from the RefleXion office. They must be based in the greater SF Bay Area and must be able to commute into the RefleXion office in Hayward daily.

What We Need

• Bachelor's of Science (BS) degree required in Mechanical Engineering, Manufacturing or similar engineering discipline

• 8+ years functional Manufacturing experience

• 5+ years of experience with complex electromechanical equipment

• 3+ years of experience in a functional management role

• Experience integrating and troubleshooting complex robotic electromechanical systems and related software

• Technical expertise across a variety of manufacturing processes: precision machining, PCA's, cable assembly, manual assembly & semi-automation

• Understanding of FDA QSR's and ISO 13485

• Extensive Lean manufacturing knowledge such as visual factory, poka-yoke, 5S, waste elimination, and kaizen

• Demonstrated ability to be a proactive and collaborative leader in a dynamic start-up environment

• Excellent interpersonal and communication skills across all levels of the organization

• Ability to mentor manufacturing personnel and cross-functional resources on best practice manufacturing principles and the application of solid engineering judgement

• Strong attention to detail and organizational skills

• Willingness to travel occasionally

• Other duties as assigned

Ways To Stand Out

• Prior experience with radiotherapy or medical diagnostic systems preferred

• Lean Manufacturing Green Belt or Black Belt or Six Sigma Certification a plus

What You Will Love About Working with Us!

• The opportunity to work with a passionate, driven team in a pre-IPO start-up environment

• Flexible work location and schedule available for many positions - see above for specific work location for this position

• Competitive compensation and Pre-IPO stock option packages

• Medical (both HMO and PPO options), Dental and Vision

• Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)

• Pre-tax Commuter Benefits

• Employee Assistance Program (EAP)

• 401(k)

• 3 Weeks/Year PTO Accrual rate to start and 12 Paid Company Holidays

• Employer paid Life Insurance, short-term and long-term disability

• RefleXion Benefit Hub

• Company exclusive discounts and deals on a variety of sites and items

• Weekly catered on-site lunches as well as kitchens filled with a variety of healthy and delicious food and drinks - including an espresso machine and panini stations!
• Employee Events

• Variety of Workshops, Lunch 'n Learns, Financial Wellness education, Regular "Coffee Chats" with Executive Leadership, Scavenger Hunts, Company Milestone celebrations and more!

• Electric car charging stations on site

The pay range for this role is $115,000 - $150,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Values and Diversity

RefleXion is an equal opportunity employer. All aspects of employment including the decision to hire will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, disability/medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.