Micro Systems Engineering, Inc.
Medical Systems Engineer - Mechanical
Micro Systems Engineering, Inc., Portland, Oregon, United States, 97204
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Medical Systems Engineer - Mechanical
role at
Micro Systems Engineering, Inc. The
Medical Systems Engineer - Mechanical
will join our R&D team, working at the technical center of development for complex implantable medical devices. The role focuses on the mechanical design of active implantable devices and their accessories, collaborating with mechanical, electrical, and software teams. This position involves contributions from prototype phases through verification and validation, and into post-market product support. Overview
The position integrates mechanical design with system-level considerations to deliver cohesive implantable medical device solutions. 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 engineering 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, fault tree analysis, and root cause investigations.
Ensure design activities comply with relevant standards (e.g., IEC 60601, ISO 14971, FDA QSR, EU MDR). Document system behavior and design decisions in line with regulatory expectations.
Provide technical support for released products, including root cause analysis and implementation of design improvements. Analyze field and product performance data to drive continuous improvement.
Your Profile Education
Bachelor's Degree or higher in Mechanical Engineering, Biomedical Engineering, or related discipline. Work Experience: Minimum 5 years of experience in mechanical or systems engineering; preferably with neurostimulation or active implantable devices. Exposure to manufacturing processes for implantable devices. Understanding of human factors and usability engineering in medical systems.
Desired Technical Skills & Competencies
Proficient in mechanical design and CAD (SolidWorks or similar). Experience with mechanical prototyping and 3D printing. Knowledge of verification and validation practices (Design & Process V&V). Understanding of biocompatibility testing and materials for implantable devices. Proficiency in data processing, scripting and plotting software (e.g., VS Code, MATLAB, Python). Experience writing technical documents and manufacturing drawings. Experience with regulatory standards such as ISO 14708, IEC 60601, FDA 21 CFR 820.11, MDR and ISO 14971. Experience with requirements management tools. Project management: ability to organize, prioritize, and execute multiple projects in a fast-paced environment. Strong communication and teamwork skills; ability to collaborate across teams and present complex ideas clearly. Ability to prioritize and manage concurrent projects; strong problem-solving and analytical skills.
Location
Lake Oswego, OR hybrid position.
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Medical Systems Engineer - Mechanical
role at
Micro Systems Engineering, Inc. The
Medical Systems Engineer - Mechanical
will join our R&D team, working at the technical center of development for complex implantable medical devices. The role focuses on the mechanical design of active implantable devices and their accessories, collaborating with mechanical, electrical, and software teams. This position involves contributions from prototype phases through verification and validation, and into post-market product support. Overview
The position integrates mechanical design with system-level considerations to deliver cohesive implantable medical device solutions. 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 engineering 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, fault tree analysis, and root cause investigations.
Ensure design activities comply with relevant standards (e.g., IEC 60601, ISO 14971, FDA QSR, EU MDR). Document system behavior and design decisions in line with regulatory expectations.
Provide technical support for released products, including root cause analysis and implementation of design improvements. Analyze field and product performance data to drive continuous improvement.
Your Profile Education
Bachelor's Degree or higher in Mechanical Engineering, Biomedical Engineering, or related discipline. Work Experience: Minimum 5 years of experience in mechanical or systems engineering; preferably with neurostimulation or active implantable devices. Exposure to manufacturing processes for implantable devices. Understanding of human factors and usability engineering in medical systems.
Desired Technical Skills & Competencies
Proficient in mechanical design and CAD (SolidWorks or similar). Experience with mechanical prototyping and 3D printing. Knowledge of verification and validation practices (Design & Process V&V). Understanding of biocompatibility testing and materials for implantable devices. Proficiency in data processing, scripting and plotting software (e.g., VS Code, MATLAB, Python). Experience writing technical documents and manufacturing drawings. Experience with regulatory standards such as ISO 14708, IEC 60601, FDA 21 CFR 820.11, MDR and ISO 14971. Experience with requirements management tools. Project management: ability to organize, prioritize, and execute multiple projects in a fast-paced environment. Strong communication and teamwork skills; ability to collaborate across teams and present complex ideas clearly. Ability to prioritize and manage concurrent projects; strong problem-solving and analytical skills.
Location
Lake Oswego, OR hybrid position.
#J-18808-Ljbffr