Medical Systems Engineer - Mechanical

Biotronik•Oswego, IL

40d•Hybrid

About The Position

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 core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to 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 We are seeking a 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.

Requirements

Bachelor's Degree or higher in a technical field such as Mechanical Engineering, Biomedical Engineering, or a related discipline.
Minimum 5 years of experience in mechanical or systems engineering.
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).
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
Proven ability to organize, prioritize, and execute multiple projects in a fast-paced, detail-oriented environment.
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.

Nice To Haves

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.
Understanding of biocompatibility testing and materials for implantable

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.