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.
The Research & Development Engineer will contribute to the development of new Galvanize energy delivery devices. This role includes technical contribution to the design and development projects and execution of product verification and validation testing.
Key Requirements
Education and Training: Scientific degree in Mechanical or Biomedical Engineering with consideration given to degree level combined with experience. Other degrees within the engineering discipline are acceptable with medical device experience.
Skills and Experience:
- Experience developing state-of-the-art ablation devices/systems or similar medical devices (5+ years' Experience with B.S. in Engineering/Science. 3+ years' experience with M.S.).
- Working knowledge of relevant medical device regulations and standards (e.g., 21 CFR Part 820, ISO 13485, ISO 14971
- Proficiency in CAD software (Solidworks preferred) with experience in disposable devices.
- Ability to work and contribute effectively to a team environment while also being able to work and solve problems working independently when necessary.
- Experienced in design of experiments, structured problem solving, design verification testing and design validation testing.
- Ability to adapt quickly in a fast-paced, evolving company and operate with a high sense of urgency.
- Working knowledge on medical device prototyping (e.g., Catheter reflow, 3D Printing, Machining, Hand-Tools)
- Excellent written and verbal communication skills, including the ability to present technical information to diverse audiences.
Key Responsibilities
- Contribute to the creation and maintenance of design control deliverables in compliance with relevant regulatory standards (e.g., 21 CFR Part 820, ISO 13485).
- Develop detailed engineering specifications for components, sub-assemblies, finished devices, and packaging based on product requirements.
- Generate accurate and comprehensive engineering drawings utilizing CAD software.
- Collaborate with cross-functional teams, including R&D, Quality Engineering, Regulatory, Supply-chain, and Marketing, throughout the product development lifecycle.
- Independently or collaboratively plan, execute, and document engineering activities to meet project timelines and objectives.
- Author and review test protocols and reports to evaluate device performance, reliability, and safety.
- Perform hands-on testing and data acquisition as required.
- Design, fabricate, and evaluate prototypes to assess feasibility and performance of new product concepts and design iterations.
- Identify, analyze, and resolve technical challenges and design issues through experimentation and problem-solving methodologies.
- Prepare and deliver clear and concise presentations of technical data, analysis, and conclusions to cross-functional teams, as required.
- Contribute to risk management activities such as Hazard Analysis and FMEAs.
- Provide technical support in CAPA investigations, complaints, failure investigations, and material non-conformance.
- Responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.
At Galvanize Therapeutics, your base pay is one part of your total compensation package. This role pays between $120,000 and $145,000 per year, and your actual base pay will depend on your skills, qualifications, experience, and location.
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.