Project Engineer (Mechanical)

BioTalent; Redwood City (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

BioTalent in Redwood City, California, is seeking a Mechanical Project Engineer to design and develop mechanical components and assemblies for Class III implantable neuromodulation systems and related external accessories.

You will work with cross‑functional teams including electrical, firmware, systems, quality and regulatory to translate clinician feedback into robust designs and to support design documentation and V&V.

Qualifications

• Design mechanical components, assemblies, prototypes, and test fixtures for implantable devices.
• Perform solid modeling, tolerance stack analysis, and GD&T-based design.
• Work with vendors on prototyping and manufacturability.
• Design and run mechanical tests, investigate failure modes, and drive design changes.
• Support FDA/ISO compliant development, including ECOs, V&V, and design documentation.
• Collaborate with electrical, firmware, systems, quality, and regulatory teams.
• Work directly with physicians and clinicians to translate feedback into design requirements.
• Contribute to early-stage concept development and IP generation.
• Support risk management activities including hazard analysis and FMEA.

Responsibilities

• Design mechanical components, assemblies, prototypes, and test fixtures for implantable devices
• Perform solid modeling, tolerance stack analysis, and GD&T-based design
• Work with vendors on prototyping and manufacturability
• Design and run mechanical tests, investigate failure modes, and drive design changes
• Support FDA/ISO compliant development, including ECOs, V&V, and design documentation
• Collaborate with electrical, firmware, systems, quality, and regulatory teams
• Work directly with physicians and clinicians to translate feedback into design requirements
• Contribute to early-stage concept development and IP generation
• Support risk management activities including hazard analysis and FMEA

Skills

Tolerance stack analysis

Solid modeling

GD&T

FEA

Fatigue testing

Biomedical materials

Usability studies

Cross-functional collaboration

Communication skills

Travel willingness

Education

Bachelor's degree in Mechanical Engineering

Job description

We're hiring a Mechanical Project Engineer to design and develop mechanical components and assemblies for Class III implantable neuromodulation systems and related external accessories.

What you'll do:

• Design mechanical components, assemblies, prototypes, and test fixtures for implantable devices
• Perform solid modeling, tolerance stack analysis, and GD&T-based design
• Work with vendors on prototyping and manufacturability
• Design and run mechanical tests, investigate failure modes, and drive design changes
• Support FDA/ISO compliant development, including ECOs, V&V, and design documentation
• Collaborate with electrical, firmware, systems, quality, and regulatory teams
• Work directly with physicians and clinicians to translate feedback into design requirements
• Contribute to early-stage concept development and IP generation
• Support risk management activities including hazard analysis and FMEA

What we're looking for:

• Bachelor's degree with 3-5 years of medical device development & verification experience (Complex Class II, or Class III exposure preferred)
• Strong background in tolerance stack analysis, solid modeling, and GD&T
• FEA, fatigue testing, and biomedical materials experience preferred
• Familiarity with injection molding, welding, and implantable device manufacturing methods
• Experience with usability studies and cadaver study feedback
• Strong communication skills and ability to influence cross-functional decisions
• Willingness to travel ~10% domestically and internationally