Hybrid Medical Systems Engineer - Mechanical Design

BIOTRONIK SE & Co.KG; Lake Oswego (OR); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Micro Systems Engineering, Inc. in Lake Oswego, OR is seeking a Medical Systems Engineer - Mechanical to lead design and integration of implantable devices and accessories.

You will collaborate across electrical, manufacturing and human factors teams from prototyping through verification, validation and post-market support. The role requires a Bachelor’s in Mechanical or Biomedical Engineering, 5+ years in relevant engineering, and experience with verification/validation and regulatory standards

Qualifications

• Bachelor's Degree or higher in Mechanical Engineering, Biomedical Engineering, or related field.
• Minimum 5 years in mechanical or systems engineering, preferably with implantable devices.
• Experience with neurostimulation or similar active implantable devices is a plus.

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 (3D printing and bench testing).
• Develop and execute test plans for performance, safety, and regulatory compliance.
• Lead risk management activities (FMEA, fault tree analysis, root cause investigations).
• Ensure compliance with IEC 60601, ISO 14971, FDA QSR, EU MDR; document design decisions for regulatory expectations.
• Provide post-market engineering support and drive continuous improvement.

Skills

CAD design

3D printing

V&V

biocompatibility

Python

MATLAB

data plotting

technical writing

team collaboration

project management

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

VS Code

Job description

Micro Systems Engineering, Inc. in Lake Oswego, OR is seeking a Medical Systems Engineer - Mechanical to lead design and integration of implantable devices and accessories.

You will collaborate across electrical, manufacturing and human factors teams from prototyping through verification, validation and post-market support. The role requires a Bachelor’s in Mechanical or Biomedical Engineering, 5+ years in relevant engineering, and experience with verification/validation and regulatory standards