Senior Manufacturing System Test Engineer - 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:LinkedIn, X (formerly Twitter), Instagram, Facebook, and YouTube.About This Role The Senior Manufacturing System Test 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 regulationsGenerate 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 beamPET calibration includes the handling of radioactive tracersSupport 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&DDesign/qualify/maintain equipment, fixtures, and toolsDraft/ execute process validation (IQ, OQ, PQ, PPQ and TMV) and generate engineering reportsGenerate and maintain pFMEAsContribute to our Manufacturing Execution System (MES) by qualifying processes in the MES systemConduct training for assembly technicians as neededOther duties as assignedWhere 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 equipmentFlexible work scheduleWilling and available to begin work during standard Company business hours (~8am - ~5pm) but willing and available to transition to later business hours (~11am - ~8pm) schedule to support both 1st and 2nd Manufacturing ShiftsExperience with assembling and trouble-shooting System, Sub-System and electromechanical assemblies with tight mechanical toleranceExperience using test software or scripts for testing to support manufacturing appropriatelyWorking knowledge of FDA QSR's and ISO 13485Experience performing pFMEA, IQ, OQ, PQ, PPQ, and TMVLean manufacturing knowledge such as visual factory, poka-yoke, 5S, waste elimination, and kaizenExperience with data driven engineering methodologies such as DOE, GRR, SPC and 6 SigmaWillingness to handle radioactive chemicals during the calibration of the PET systemExperience with UNIX, LINIX operating systemsHigh attention to detail and organizational skillsExcellent document writing skillsStrong team player and interpersonal skillsWillingness to travel up to 10%Ways To Stand Out Engineering experience within radiotherapy medical device preferredLean Manufacturing or Six Sigma Certification a plusPrevious experience working with radioactive tracers desiredWhat You Will Love About Working with Us!The opportunity to work with a passionate, driven team in a pre-IPO start-up environmentFlexible work location and schedule available for many positions - see above for specific work location for this positionCompetitive compensation and Pre-IPO stock option packagesMedical (both HMO and PPO options), Dental and VisionHealth Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)Pre-tax Commuter BenefitsEmployee Assistance Program (EAP)401(k)3 Weeks/Year PTO Accrual rate to start and 12 Paid Company HolidaysEmployer paid Life Insurance, short-term and long-term disabilityRefleXion Benefit Hub -Company exclusive discounts and deals on a variety of sites and itemsWeekly 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 siteThe pay range for this role is $100,000 - $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.