Senior Engineer, Validation and Reliability

Prepares installation and test validation procedures/protocols to ensure product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards and current industry practices.
Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
May also investigate and troubleshoot problems and determine solutions. Maintains validation documentation and files.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
Job requires an understanding and application of procedures and concepts of own discipline.
The job requires attention to detail in making evaluative judgements based on the analysis of factual information.
This job typically requires a degree or equivalent and a minimum of 2 or more years experience.
Actual job title: Senior Imaging & Testing Specialist

Position summary:
The Senior Imaging & Testing Specialist is responsible for the operation, maintenance, and optimization of advanced imaging systems that support the development of innovative Neurovascular endovascular therapies.
This role partners closely with R&D, Clinical, Marketing, and Medical Education teams to execute bench-top, simulated-use, and non-human vascular testing of medical devices throughout the product development lifecycle.
The ideal candidate combines expertise in angiography imaging systems, laboratory operations, radiation safety, and endovascular procedure workflows to support high-quality testing environments that accelerate innovation and support successful product development.
Essential duties & responsibilities: (detailed description)
Advanced Imaging & Laboratory Operations
Operate and optimize monoplane and biplane fluoroscopy imaging systems to support R&D and bench-top device testing.
Support advanced imaging applications, including 2D and 3D angiographic visualization, vessel roadmapping, and imaging acquisitions.
Perform system setup, calibration, software updates, troubleshooting, and routine maintenance of imaging equipment.
Coordinate with vendors and technical service providers to resolve equipment issues and maintain operational readiness.
Maintain imaging system documentation, compliance records, and medical physicist reports.
Preclinical Device Testing Support
Prepare, assemble, and maintain in vitro vascular models used for device evaluations.
Support simulated-use testing, proof-of-concept studies, design verification activities, physician events, and product demonstrations.
Provide technical expertise on imaging workflows and endovascular procedural techniques during device evaluations.
Laboratory Readiness & Inventory Management
Maintain laboratory organization, cleanliness, and operational readiness.
Support inventory of bench-top testing supplies, consumables, and laboratory equipment.
Ensure testing spaces are appropriately configured for R&D activities, physician events, and internal training.
Safety & Compliance
Promote a culture of safety and compliance within all laboratory operations.
Support radiation safety programs, dosimetry monitoring, personal protective equipment (PPE) compliance, and ALARA practices.
Ensure laboratory activities comply with applicable company policies and regulatory requirements.
Technical Leadership
Serve as a subject matter expert for fluoroscopic imaging systems, and angiography suite operations.
Provide guidance to teams regarding imaging best practices and capabilities.

Education & special trainings:
Associate's or bachelors degree in radiologic technology, Cardiovascular Technology, Biomedical Engineering Technology, or related technical discipline preferred.
Relevant technical certifications in imaging, radiologic technology, or cardiovascular technology are preferred.

Qualifications & experience:
Experience operating angiography, fluoroscopy, catheterization laboratory, or interventional imaging systems.
Experience with Philips Azurion, Siemens ICONO, GE, or similar imaging platforms is highly desirable.
Experience healthcare technology environments is highly desirable.
Familiarity with endovascular, neurovascular, peripheral vascular, or interventional procedural workflows is highly desirable.

Physical & mental requirements:
Ability to lift, carry, and move laboratory equipment, vascular models, and testing supplies up to 15 pounds.
Ability to wear radiation protection equipment for extended periods during testing activities.
Ability to stand, walk, bend, and perform laboratory setup and cleanup activities as required.

Fully onsite 47900 Bayside Parkway Fremont, CA 94538

This is a specialized, highly skilled role. This is the equivalent to a radiation technician in a hospital or clinic. HM is OKAY with someone who can work 3-days a week T-Th, as this role may be hard to fill, and we may need to go with someone who already has another job.

Education:
Associate's or Bachelor's degree in Radiologic Technology, Cardiovascular Technology, Biomedical Engineering Technology, or related technical discipline preferred.
Relevant technical certifications in imaging, radiologic technology, or cardiovascular technology are preferred.

Must haves:
Have to have education background or work experience in Cath lab (Angiography)
Philips or Siemens experience
Knowledge of Lab operations and radiation safety

Nice to have:
Knowledge of endovascular procedure workflows

IV process:
2-3 rounds
1st round Teams meeting with HM and HM leadership
2nd round onsite meeting with HM, la b lead and senior principal engineer
Possible 3rd round, if needed

Environments for strong match:
Hospital experience / Cath lab
Medtronic (endovascular division)
Will consider those with tech degree and some hands on Cath lab experience
Good communication skills needed, will be interacting with customers (Health care professionals) and other personnel

Typical day to day:
Role does not deal with live patients, 3D printed parts/tubes
Support setting up patient, control room support for physician
Post-op clean up, resetting room for new tests, Inventory assistance
Radiation safety procedure (ensure proper training and PPE for all involved) level of accountability for contingent with CA radiation procedures
What timeframe should the employee feel comfortable completing job duties 100% on their own:
Prior Cath lab experience less than 30 days
Less experience up to 90 days