Manufacturing Test Development Engineer - ONSITE

Who We Are

RefleXion transforms radiopharmaceuticals from diagnosing cancer to actively controlling delivery of external-beam radiotherapy by leveraging individual tumor biology. Designated an FDA Breakthrough Device, RefleXion’s SCINTIX™ biology-guided radiotherapy automates targeting and motion management to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. In strategic collaborations with radiopharmaceutical companies, RefleXion is co-developing and co-commercializing disease-specific radiotracers for difficult to treat late-stage cancers.

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

About This Role

The Manufacturing Test Development Engineer plays a key role in implementing best-in-class subsystem test processes for a revolutionary radiation therapy medical device.  Major objectives are to develop, qualify, and routinize the manufacturing subsystem tests to support commercial ramp and meet company objectives for quality, delivery, and cost.  The successful candidate will demonstrate a solid understanding of complex electrical test equipment, electrical test process and best practice methodologies and in compliance with regulatory requirements.

What You Will Be Doing

• Partner with R&D engineers to develop the functional test processes for new products and transfer into routine manufacturing.
• Develop electrical functional tests for subsystem boxes to ensure proper function before integration or shipment to the field.
• Generate detailed test documentation (MPI’s, travelers, BOM’s), and conduct training for test technicians as needed.
• Design/oversee test equipment, fixtures and tools are developed to meet quality, safety and performance objectives.
• Ensure product quality by implementing effective process controls and conduct pFMEA risk assessments.
• Implement Lean manufacturing practices to optimize product quality and manufacturing efficiencies.
• Execute process validation through IQ, OQ, PQ, PPQ and TMV.
• Develop tests to ensure field replacement parts are qualified before shipment and that returned subsystems can be repaired and tested before returning to stock.
• Ensure manufacturing compliance with all Safety and Quality regulations.
• Troubleshoot component/system failures during assembly and as part of corrective action investigations.
• Generate engineering reports, justifications and presentations to support ECO’s, NCR’s, complaints and CAPA’s.
• Drive design and process optimization for manufacturability, serviceability and reliability as part of continuous improvement activities.
• 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 in Electrical Engineering or similar Engineering discipline required.
• Minimum of 5 years direct experience as a Manufacturing/ NPI/R&D engineer in a relevant environment
• 3+ years of experience with complex electromechanical equipment 
• 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
• Experience interacting with suppliers to ensure product conformance, cost effectiveness and outsourcing initiatives
• 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

• Manufacturing / NPI / R&D engineer experience in the radiotherapy medical device field
• Professional experience LabVIEW and Python  

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 – hybrid work environment for many positions
• 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 $75,000 - $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.