Senior Product Development Engineer - ONSITE at RefleXion

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.

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About This Role 

The Senior Product Development Engineer will play a key role in the development, support, commercialization, and improvement of a complex electromechanical, radiation therapy medical device.  Major objectives are to support the design, prototyping, and testing of product improvements, support the maintenance of Research & Development (R&D) devices, and to facilitate design transfer of R&D device improvements to manufacturing.  This role requires demonstrated technical competence in systems engineering, system integration, and hands-on system problem solving, technical depth in mechanical or electrical engineering, and very effective communication and interpersonal skills.  This role will serve as a primary engineering liaison between R&D and New Product Introduction (NPI) and will be an evolving position in a start-up company environment.

What You Will Be Doing 

• Gain systems-engineering level knowledge of highly-complex medical device
• Execute R&D device activities including regular health checks, maintenance, troubleshooting and repair, system calibrations, Software/Hardware upgrades, revision control, testing, debugging and data analysis of measurement performance
• Keep performance and maintenance records on the equipment.  Maintain physical configuration reports, and plan maintenance and upgrade paths
• Complete initial diagnosis of any system issue, drive to uncover root cause, and devise or drive a team to define solutions for complex problems. Support the detailed analysis and tradeoffs for the various solutions, develop plan of action, and effectively communicate plan to colleagues
• Support subsystem builds, full system builds, and system integration during product improvement developments, including hands-on assembly
• Troubleshoot component/system failures during assembly and as part of corrective action investigations
• Help create and execute test plans for complex subsystems. This will involve integration of subsystems, testing against design tolerances and specifications, analyzing test data, and generation of reports
• Partner with R&D engineers to develop the assembly and test manufacturing documentation (Manufacturing Process Instructions (MPIs), travelers, Bill of Materials (BOM)) for product improvements and partner with NPI to transfer into routine manufacturing
• 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 

• Minimum of 5 years’ direct experience as a R&D and/or Manufacturing Engineer in a relevant environment (medical device and/or capital equipment)
• Bachelor of Science (BS) degree in mechanical, electrical, systems engineering, physics, or similar discipline OR 15 years direct, diagnostic / troubleshooting experience on complex capital equipment
• Experienced with integrating and troubleshooting complex electromechanical systems and related software
• Demonstrated experience with all phases of product development including design, bring-up, debug, and transition to manufacturing
• Able to isolate and debug hardware and software problems in complex systems
• Demonstrated competency and understanding of system electronics
• Expertise with electrical test equipment including logic analyzers, oscilloscopes, and digital multi-meters
• Strong attention to detail and organizational skills
• Strong communication and documentation skills
• Ability to be proactive and collaborative in a dynamic start-up environment
• Ability to work on your feet, standing for long periods of time
• Must be able to safely lift 50 lbs
• Occasional domestic travel may be required

Ways To Stand Out 

• Experience with radiation therapy beam systems highly desirable
• Previous experience working in a highly regulated environment and familiarity with FDA requirements

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 $100,000 - $148,000 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.