Operations Manager, Electrical and Capital Equipment

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 Senior Research & Development Engineer will contribute to the development of new pulsed-field energy delivery devices. This role includes technical contribution to the design and development projects and execution of product verification and validation testing.

Must Have Qualifications

Education and Training:

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

Skills and Experience:

Experience developing state-of-the-art electrosurgical systems or similar medical devices ideally including experience in developing both electrical and mechanical medical instruments (5+ years).

Strong working knowledge of medical device design controls and quality systems

Strong CAD skills with experience in device design (SolidWorks preferred)

Experience commercializing medical devices and/or medical equipment

Strong communication skills a must (verbal and written)

Ability to work in and contribute effectively to a team environment, while also being able to

solve problems independently when necessary.

Familiarity with design control processes and testing required for development of sterile single-use catheters and/or electromechanical devices.

Experience selecting and working with high quality vendors to ensure timely delivery of product meetings its product specifications and satisfying user needs.

Knowledge of domestic and international regulations affecting medical devices

Ability to adapt quickly in a fast-paced, evolving company and operate with a high sense of urgency

Key Responsibilities:

Key contributor on development and design control inputs required for Advanced treatment systems.

Work with Quality, Clinical and Regulatory personnel to create robust regulatory submissions.

Work with cross-functional resources to resolve design issues, define key characteristics, dimensional tolerances, and manufacturing procedures.

Support process and test development through the design of fixtures and equipment.

Present data and conclusions to support research and/or development activities.

Write and review test protocols, reports, and intellectual property disclosures.

Provide technical support to Quality for CAPA investigations, complaints, and failure investigations.

What Galvanize Offers:

Medical, Dental, Vision, Life Insurance, LTD/STD

100% company paid medical coverage for employees

Flexible Paid Time Off

Paid Parental Leave

Company sponsored 401(k)

Due to the nature of our business and the role, please note that Galvanize Therapeutics may require that you show current proof of vaccination against certain diseases including COVID-19.

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.