Staff Mechanical Engineer

Visby Camera Corporation; San Jose (CA); On-site; USD 175,000 - 200,000; Full time

Job summary

An ambitious biotech startup is seeking a Staff Mechanical Engineer to drive the design and development of innovative medical diagnostic devices. In this dynamic role, you will leverage your extensive experience in medical device development to create groundbreaking products that redefine infectious disease testing. Collaborating with a passionate team, you will engage in hands-on design, conduct critical analyses, and contribute to the advancement of healthcare technology. This is an exciting opportunity to make a significant impact in a fast-paced environment while enjoying competitive benefits and a commitment to diversity and inclusion.

Benefits

Competitive Health Insurance

Flexible Paid Time Off

Company-Funded HSA Option

11 Holidays

Qualifications

• 7+ years of experience in medical device development.
• Expertise in Solidworks and GD&T for design specifications.

Responsibilities

• Design and develop parts for medical diagnostic devices.
• Lead design development processes and support manufacturing.

Skills

Medical Device Development

Solidworks (3D and 2D)

GD&T ASME Y 14.5M - 1994

Fluid Handling

Test Method Development

Excellent Communication Skills

Education

BS in Bioengineering or Mechanical Engineering

MS in Bioengineering or Mechanical Engineering

Tools

Solidworks

Job description

About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

About the Role

The Staff Mechanical Engineer will be a key contributor in the design and development of disposable medical diagnostic devices. This candidate will have a proven track record of developing medical devices and bringing them to market. The role requires excelling in a dynamic and exciting workplace environment.

How You'll Make An Impact

1. QMS responsibilities
2. Design and develop parts and modules for novel diagnostic molecular test products.
3. Define design requirements, specifications, and drawings to ensure product functionality.
4. Transfer design to manufacturing and support vendor selection for high volume scale-up.
5. Lead design development processes, contribute to Device History Files (DHF), and lead design reviews.
6. Perform or supervise experiments to verify mechanical and assay performance.

Non-QMS responsibilities

1. Research and develop candidate designs or methods for future products, from concept to prototype.
2. Conduct analyses such as FEA and tolerance stacking to ensure proper product function.
3. Contribute to grant writing activities.
4. Write patent disclosures.
5. Perform other duties as assigned.

On Your First Day, We’d Like You to Have

• BS in Bioengineering or Mechanical Engineering; MS preferred.
• More than 7 years of experience in medical device development.

It’s Great If You Have

• Expertise in Solidworks (3D and 2D), GD&T ASME Y 14.5M - 1994.
• Experience designing precision injection molded components and elastomers for high-volume, low-cost medical devices.
• Experience with products involving precise fluid handling.
• Knowledge of design control processes for Class 2 medical devices.
• Experience in test method development and validation.
• Excellent verbal and written communication skills.
• Ability to work effectively under pressure while maintaining high ethical standards.

Salary Range

$175,000 - $200,000 a year

(Salary range for candidates based in San Jose, CA)

Compensation depends on geographical location, qualifications, skills, competencies, and experience, and may fall outside the indicated range.

More About Our Benefits

Visby offers competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also provide flexible paid time off, 11 holidays, and other benefits.

Visby is proud to have received the 2023 Cigna Healthy Workforce Designation.

Additional Information

We value diversity and inclusion, and do not discriminate based on race, color, religion, sex, gender, age, disability, or other protected categories.

Full COVID vaccination is required; reasonable accommodations are considered for medical or religious reasons.