Senior NPI Engineer - HYBRID - RefleXion

Hayward, CA

About the Job

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 NPI Engineer will provide engineering leadership and support in the development and commercialization of a complex electromechanical, radiation therapy medical device. The initial major objectives of this role will be to establish production processes and complete Design Transfer of the initial commercial product to sustain that product through feature upgrades, cost reductions and other related improvement projects. The successful candidate for this position must demonstrate technical competence in systems-engineering and process development, as well as very effective interpersonal skills. This role will serve as the primary engineering liaison between R&D and Manufacturing.

What You Will Be Doing

Collaborate with design engineers to establish the production processes ensuring all requirements are met for safety and performance.

Primary owner of manufacturing builds during product development, including hands-on assembly.

Generate detailed documentation (drawings, schematics, MPIs, Travelers, BOMs, Routings) in support of manufacturing assembly.

Ensure product quality through pFMEA risk assessment and implementation of effective process controls.

Execute process validations (IQ OQ PQ & TMV).

Design and oversee the development of assembly equipment, fixtures and tools ensuring they meet quality, safety, and performance objectives.

Troubleshoot machine failures at both the system and subsystem level, during prototype assembly and as part of pilot builds leading up to Design Transfer.

Ensure manufacturing process compliance and support V&V testing for FDA 510(k) submission and clearance.

Work closely with materials management, Incoming Inspection, and vendors to assure that purchased material meets specifications in preparation for Design Transfer.

Investigate quality issues for root cause and implement corrective actions.

Generate engineering reports, justifications and MTFs to resolve NCRs, complaints, and CAPA’s.

Support packaging and transportation of system, machine assembly, and system calibration during field installations.

Other duties as assigned.

Where You Will Do This Job

Hybrid - This position will allow the successful candidate to work on a Hybrid work location schedule. They must be based in the greater SF Bay Area and must be able to commute into the RefleXion office in Hayward 1-4 days a week, depending on the role.

What We Need

Bachelor of Science (BS) degree in mechanical, electrical, biomedical, industrial engineering or physics, or similar/related engineering discipline required.

Minimum of 6 years direct professional experience as a Manufacturing, NPI, R&D or similar engineer in medical device capital equipment development and/or manufacturing.

Experienced with integrating and troubleshooting complex robotic electromechanical systems and related software.

Demonstrated competency and high-level understanding of system functions.

Demonstrated strong design for manufacturing (DFM) knowledge including mistake-proofing, simplification, standardization, and testing.

Experienced with data-driven engineering methodology such as FMEA, reliability testing, GRR, DOE, V&V.

Knowledgeable in system packaging, shipping, installing and field service activities.

Working knowledge of and practical experience with FDA QSRs, ISO 13485 and IEC 60601 and collateral standards.

Strong attention to detail and organizational skills.

Excellent document writing skills.

Ability to be a proactive and collaborative leader in a dynamic start-up environment.

Ability to provide guidance and leadership to less experienced engineers.

Able to run small to large projects from initiation to production launch.

Ability to work in the office and on a manufacturing floor in an FDA regulated radioactive environment.

Occasional travel required.

Ways To Stand Out

Experience with computer systems, operating systems, server assemblies and electrical assemblies in general.

Experience with imaging or radio therapy systems (CT, MRI, PET, SPECT, Medical Linacs) highly 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 $115,000 - $175,000 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.

Source : RefleXion