Senior Product Development Engineer

2 weeks ago

Hayward, California, United States BioSpace, Inc. Full time
About RefleXion

RefleXion is a pioneering company in the field of radiopharmaceuticals, elevating them from diagnostic tools to therapeutic guides. Our SCINTIX biology-guided radiotherapy has been designated an FDA Breakthrough Device for lung tumors, aiming to overcome long-standing barriers in definitive radiotherapy for metastatic disease.

About This Role

The Senior Product Development Engineer will play a crucial role in the development, support, commercialization, and improvement of our complex electromechanical, radiation therapy medical device. Key objectives include supporting design, prototyping, and testing of product improvements, maintaining Research & Development (R&D) devices, and facilitating design transfer of R&D device improvements to manufacturing.

Responsibilities
  • Gain systems-engineering level knowledge of highly-complex medical devices
  • 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 various solutions, develop a plan of action, and effectively communicate it 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, involving integration of subsystems, testing against design tolerances and specifications, analyzing test data, and generating reports
  • Partner with R&D engineers to develop 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
Requirements
  • Minimum of 7 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
Preferred Qualifications
  • Experience with radiation therapy beam systems highly desirable
  • Previous experience working in a highly regulated environment and familiarity with FDA requirements
What We Offer
  • 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
  • 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

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