Medical Systems Engineer - Mechanical

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

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company’s corevalues - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling usto inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

Please join us as:

Medical Systems Engineer - Mechanical

Systems Engineer - Mechanical Engineer to join our R&D team. This role places you at the technical center of development of complex implantable medical devices focusing on the design of mechanical aspects of active implantable devices and their accessories. The role involves collaboration across multidisciplinary teams including mechanical, electrical and software teams. This role involves contributions from prototype phases through verification and validation, all the way to post-market product support.

Key Responsibilities

System Design & Integration

• 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.

Prototyping & Development

• Support rapid prototyping, including 3D printing and bench testing.
• Apply iterative development methods to refine mechanical components.
• Verification, Validation & Testing
• 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.
• Regulatory & Standards Compliance
• 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.

Post-Market Engineering

• 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 a technical field such as Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Work Experience
• Industry Experience: Minimum 5 years of experience in mechanical or systems engineering and preferably:
  • Experience with neurostimulation or other similar 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
• Proficiency in at least one data processing, scripting and plotting software (e.g. VS Code, Matlab, python)
• Experience writing technical documents and working drawings for manufacturing
• Experience working with regulatory standards such as ISO 14708, IEC 60601, FDA 21 CFR 820.11, MDR and ISO 14971.
• Experience working in requirements management tools
• Project Management Skills: Proven ability to organize, prioritize, and execute multiple projects in a fast-paced, detail-oriented environment.
• Communication & Teamwork: Strong interpersonal and communication skills, with the ability to effectively collaborate across teams and present complex ideas clearly.
• Ability to prioritize effectively and work on concurrent projects.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills including technical report writing skills.

Location

• Lake Oswego, OR this is a hybrid position.

Working hours: Full-time

Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee