Senior / Staff Manufacturing System Engineer - ONSITE - RefleXion Medical

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 Senior / Staff Manufacturing System Engineer will play a key role in implementing best-in-class manufacturing assembly and test processes for our system. Major objectives are to support, improve, and routinize the manufacturing assembly and test processes to support commercial ramp and meet company objectives for quality, delivery and cost.  The successful candidate will demonstrate a solid understanding of manufacturing complex, high-power, permanently installed capital equipment.  This role will be an evolving position in an exciting, start-up company environment.

What You Will Be Doing 

• Ensure manufacturing compliance with all Safety and Quality regulations
• Generate and maintain system calibration and test manufacturing documentation (MPI's, travelers, BOM's) via Change Orders (CO's)
  • Calibration will include PET, CT and 6MV X-Ray treatment beam
  • PET calibration includes the handling of radioactive tracers
• Support Production Activities by resolving product/process nonconformance via Nonconformance Reports (NCMR's), Change Order (CO's), Temporary Deviation (TD's), Complaints, Corrective Actions/Preventative Actions (CAPA's)
• Continuously improve the product and process through leading a cross-functional team of Manufacturing, Quality, Supply Chain, and R&D
• Design/qualify/maintain equipment, fixtures, and tools
• Draft/ execute process validation (IQ, OQ, PQ, PPQ and TMV) and generate engineering reports
• Generate and maintain pFMEAs
• Contribute to our Manufacturing Execution System (MES) by qualifying processes in the MES system
• Conduct training for assembly technicians as needed
• 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 Degree (BS) in engineering, physics or closely related field required 
• Minimum of 5 years direct experience as a Manufacturing, NPI, and/or R&D engineer in a relevant environment (laboratory equipment, military, pharmaceutical, aerospace or other highly regulated industry)
• 3+ years of engineering experience with complex capital equipment 
• Experience with assembling and trouble-shooting System, Sub-System and electromechanical assemblies with tight mechanical tolerance
• Experience using test software or scripts for testing to support manufacturing appropriately
• Working knowledge of FDA QSR's and ISO 13485
• Experience performing pFMEA, IQ, OQ, PQ, PPQ, and TMV
• Lean manufacturing knowledge such as visual factory, poka-yoke, 5S, waste elimination, and kaizen
• Experience with data driven engineering methodologies such as DOE, GRR, SPC and 6 Sigma
• Willingness to handle radioactive chemicals during the calibration of the PET system
• Experience with UNIX, LINIX operating systems
• High attention to detail and organizational skills
• Excellent document writing skills
• Strong team player and interpersonal skills
• Willingness to travel up to 10%

Ways To Stand Out 

• Engineering experience within radiotherapy medical device preferred
• Lean Manufacturing or Six Sigma Certification a plus
• Previous experience working with radioactive tracers desired

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 $110,000 - $165,000 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.