Mechanical Systems Engineer - Implantable Medical Devices

Micro Systems Engineering, Inc.; Portland (OR); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Micro Systems Engineering, Inc. is seeking a Systems Engineer – Mechanical Engineer to advance the design of implantable medical devices. You will lead mechanical design and system integration across multidisciplinary teams, from prototype through verification and post-market support.

The role requires 5+ years in mechanical or systems engineering for implantable devices, strong CAD skills, and experience with regulatory standards. Lake Oswego hybrid work model

Qualifications

• Bachelor's degree in a technical field such as Mechanical or Biomedical Engineering.
• Minimum 5 years of experience in mechanical or systems engineering, preferably in medical devices.
• Experience with neurostimulation or active implantable devices is a plus.
• Exposure to manufacturing processes for implantable devices and human factors usability.

Responsibilities

• Lead mechanical design and system integration of implantable and accessory devices.
• Define and manage subsystem requirements and interfaces.
• Collaborate with electrical, manufacturing and human factors teams to ensure cohesive system design.
• Support rapid prototyping, including 3D printing and bench testing.
• Apply iterative development methods to refine mechanical components.
• Develop and execute test plans to ensure compliance with performance, safety, and regulatory requirements.
• Support and lead risk management activities, including FMEA and root cause investigations.
• Ensure design activities comply with standards (IEC 60601, ISO 14971, FDA QSR, EU MDR).
• Document system behavior and design decisions for regulatory expectations.
• Provide technical support for released products and implement design improvements.
• Analyze field and product performance data to drive continuous improvement.

Skills

Mechanical design

CAD

3D printing

Verification & Validation

Regulatory knowledge

Technical writing

Project management

Cross-functional collaboration

Biocompatibility

Python

Education

Bachelor's Degree in Mechanical Engineering or Biomedical Engineering

Tools

Solidworks

Matlab

Python

VS Code

Job description

Micro Systems Engineering, Inc. is seeking a Systems Engineer – Mechanical Engineer to advance the design of implantable medical devices. You will lead mechanical design and system integration across multidisciplinary teams, from prototype through verification and post-market support.

The role requires 5+ years in mechanical or systems engineering for implantable devices, strong CAD skills, and experience with regulatory standards. Lake Oswego hybrid work model