Manager, New Product Development

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 New Product Development (NPD) Engineering Manager is a technical leadership role within the Research & Development organization responsible for leading the engineering execution and technical strategy of assigned medical device product lines from concept through commercialization. This individual serves as the technical owner for product development activities, guiding multidisciplinary engineering teams to deliver innovative, high-quality products that meet clinical needs, customer expectations, regulatory requirements, and business objectives.
• The ideal candidate is a highly respected technical leader with deep medical device development experience, particularly in catheter-based technologies and energy delivery systems. They combine strong engineering fundamentals with hands-on product development expertise, having demonstrated experience designing products, building prototypes, executing verification testing, and leading teams through complex development challenges.

Qualifications

• Education and Training:
• • Scientific degree in Mechanical, Electrical, 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:
• • Minimum of 10 years of medical device product development experience.
  • Demonstrated technical leadership experience leading multidisciplinary engineering teams or complex product development programs.
  • Hands-on experience designing, developing, and commercializing medical devices.
  • Strong experience with Design Controls, product development processes, and engineering documentation required for regulated medical devices.
  • Experience leading technical teams through concept development, prototyping, design verification, and commercialization.
  • Demonstrated experience with hands-on engineering activities including CAD design, prototype builds, engineering testing, and design verification activities.
  • Strong understanding of product architecture, requirements development, design trade-offs, and technical risk management.
  • Experience collaborating with cross-functional teams including Regulatory Affairs, Design Assurance, Process Development Engineering, Quality Assurance, Clinical Affairs, Manufacturing, and Program Management.
  • Excellent technical communication, leadership, and problem-solving skills.
  • Ability to influence technical decisions and drive alignment across multidisciplinary teams.
• Other:
• • Domestic and international travel (less than 20%) to collaborate with external vendors.

What you'll do

• Own technical execution for assigned product lines, providing engineering leadership across multiple New Product Development programs, product generations, and lifecycle activities from concept through commercialization and sustaining engineering.
• Define product and technical strategy, including system architecture, engineering execution plans, and key technical decisions, ensuring alignment with clinical needs, customer requirements, business objectives, and regulatory expectations.
• Lead cross-functional product development, translating customer and clinical needs into engineering requirements, design inputs, product specifications, and integrated solutions across mechanical, electrical, software, and manufacturing disciplines.
• Provide technical leadership for Design Controls and product development, including Design Inputs/Outputs, Design Verification, Design Reviews, technical documentation, and Design History File requirements.
• Drive product risk management and technical decision-making, partnering with Design Assurance to identify, assess, mitigate, and document product risks while leading technical reviews and resolving complex engineering challenges.
• Ensure design-for-manufacturability and successful Design Transfer, partnering with Process Development Engineering to incorporate manufacturing, assembly, and process requirements throughout product development and commercialization.
• Lead and develop engineering talent, providing technical mentorship, coaching, performance management, career development, and recruitment to build a strong and capable engineering organization.
• Maintain hands-on technical leadership, providing guidance on engineering activities such as CAD, prototyping, engineering builds, verification testing, tolerance analysis, troubleshooting, and evaluation of technical trade-offs.
• Partner with cross-functional stakeholders including Clinical Affairs, Marketing, Regulatory Affairs, and Program Management to ensure technical execution meets customer needs, regulatory requirements, program milestones, resources, and business priorities.
• Support regulatory and product lifecycle activities, providing technical expertise for regulatory submissions, responses to regulatory questions, product improvements, design changes, and sustaining engineering.
• Champion engineering excellence and continuous improvement, promoting innovation, robust design practices, disciplined engineering processes, and continuous improvement across the R&D organization.

This role pays between $185,000 and $210,000 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.