Senior Mechanical Engineer

black.ai; San Francisco (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Healthcare, dental and vision

401k with company match

Industry leading paid time off (20 days/year + holidays)

Meals and snacks provided

Professional development support

Flexible working hours

Job summary

black.ai is seeking a Senior Mechanical Engineer in San Francisco to lead the design and development of advanced implantable medical devices. This role requires 5+ years of experience and strong proficiency in CAD tools like SolidWorks and Creo. You will manage product architecture, ensure design for manufacturability, and mentor junior engineers. The position offers comprehensive benefits including healthcare, 401k matching, and generous PTO. Flexible hours and opportunities for travel are also provided.

Qualifications

• 5+ years of experience developing Class III active implantable medical devices from concept through first-in-human.
• Experience with manufacturing processes like machining, microfabrication, and laser welding.
• Strong understanding of design controls, risk management (FMEA), and regulated product development.

Responsibilities

• Lead mechanical design and development of implantable medical devices.
• Own product architecture, including materials selection and packaging.
• Collaborate cross-functionally with engineering and regulatory teams.

Skills

Mechanical Engineering

CAD proficiency (SolidWorks, Creo)

Class III active implantable medical devices

Education

Bachelor's degree in Mechanical Engineering, Materials Science, or related field

Tools

SolidWorks

Creo

Job description

Senior Mechanical Engineer, Product Development

Location: San Francisco

Type: Full-Time (on-site)

Role Overview

We are seeking a Senior Mechanical Engineer in the Product Development group to lead the design and development of next‑generation implantable medical devices. This role will focus on mechanical architecture, system integration, and product realization—from early concept through first‑in‑human readiness.

You will play a key role in shaping product design, driving technical decisions, and mentoring junior engineers.

Key Responsibilities

• Lead mechanical design and development of implantable medical devices and supporting external hardware
• Own product architecture, including materials selection, packaging, and structural design
• Translate system requirements into robust engineering solutions and design specifications
• Plan and execute verification and validation activities (DVT, reliability, environmental testing)
• Drive design for manufacturability (DFM) and support transfer to manufacturing
• Collaborate cross‑functionally with electrical, firmware, clinical, regulatory, and quality teams
• Manage external partners (CMs, suppliers, test labs) to ensure design intent and timelines are met
• Provide technical leadership and mentorship to junior engineers

Required Qualifications and Skills

• Bachelor’s degree in Mechanical Engineering, Materials Science, or related field (advanced degree preferred)
• 5+ years of industry experience developing Class III active implantable medical devices from concept through first‑in‑human
• Strong proficiency in CAD (e.g., SolidWorks, Creo)
• Experience with implantable materials, hermetic or semi‑hermetic packaging, and biocompatibility considerations
• Demonstrated experience with manufacturing processes (e.g., machining, microfabrication, laser welding, molding, assembly)
• Experience working with contract manufacturers and external development partners
• Solid understanding of design controls, risk management (FMEA), and regulated product development

Bonus Skills

• Experience with neurostimulation or implantable electronic systems
• Familiarity with hermetic sealing approaches (ceramic, titanium, glass)
• Experience with flexible circuits, thin‑film technologies, or microfabrication
• Strong understanding of GD&T and tolerance stack analysis
• Experience in early‑stage or startup environments
• Hands‑on prototyping and lab testing experience

Reporting Structure

This role is an integral part of the product team and reports directly to the VP of Engineering.

Benefits

• US standard
• Healthcare, dental and vision
• 401k with company match
• Industry leading paid time off (PTO - 20days/year + holidays)
• Meals and snacks provided
• Professional development support and training opportunities
• Flexible working hours and travel opportunities (We have sites in Australia, UK and US)