About Galvanize Therapeutics

Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.

About the role

The Clinical Research Engineer (CRE) position reports to the Sr. Principal Research Engineer within R&D. In this position, the CRE utilizes their in-depth preclinical, technical and design control knowledge to discover, define, develop, and validate new product solutions for Pulsed Electric Field Systems. Their primary focus is to understand user needs, establish clinical and engineering requirements, consider clinical risks and identify solutions to guide product development. They also help explore additional clinical applications for Galvanize products, as well as future opportunities to optimize product integration into the clinical setting.

Qualifications

Education: Scientific degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or similar. Other degrees within the engineering discipline are acceptable with medical device experience.

Experience & Requirements:

• Minimum of 5 years of experience in medical device industry required
• Minimum of 2 years of preclinical/clinical research and design control experience
• Experience collaborating with physicians to gather clinical feedback and integrate insights into actionable solutions
• Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to ensure project success
• Experience leading hands-on product evaluation testing in a pre-clinical lab setting
• Experience developing design validation strategy, protocol creation and testing
• Experienced driving complex medical devices through regulatory submission
• Fluent in medical terminology and sound knowledge of anatomy
• Self-starter needing minimal supervision
• Self-directed execution of real-time decisions and changes
• Willingness to mentor more junior team members
• Excellent verbal and written communications skills required including presentation of technical content
• Ability to travel up to 25% of the time, internationally and domestic

What you'll do

• Coordinate, design, and perform preclinical studies (non-GLP and GLP) to address targeted research objectives and support regulatory submissions
• Collect, analyze, interpret, and distribute research findings that address research objectives and drive informed strategic decisions
• Support design verification and validation requirements
• Assess potential clinical risks and mitigations to drive appropriate product design
• Drive decision making and escalate key issues quickly
• Generate “Best Practice” guidelines and white papers
• Integrate investigational outcomes into meaningful advances to therapeutic objectives
• Coordinate with and mentor Associate Research Engineers in performing experiments and guiding their professional growth
• Generate and develop intellectual property aligned with strategic objectives
• Support other research objectives, as appropriate
• Keep the organization’s vision and values at the forefront of decision making and action.

This role pays between $150,000 and $170,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.

Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.

Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.