Location: Chicago, IL
Job Type: Full-Time
Experience Level: Mid-Level (5+ Years)
About Us:
OLI is a leader in innovative healthcare solutions, specializing in life-saving technologies for patients requiring renal replacement therapy. We're looking for a passionate and experienced Mechanical Engineer to join our multidisciplinary team and drive the design and development of next-generation medical devices that make a real impact.
Position Summary:
As a Mechanical Engineer, you will play a key role in the end-to-end development of renal replacement devices, from concept through commercialization. Your experience in medical device design, particularly in the dialysis or broader renal space, will be vital to ensuring compliance, performance, and safety standards. This is a hands-on engineering role requiring close collaboration with R&D, regulatory, clinical, and manufacturing teams.
Key Responsibilities:
Lead and contribute to the design, prototyping, and testing of renal replacement devices (e.g., hemodialysis systems, dialyzers, blood and fluid circuits).
Apply engineering principles to develop innovative solutions for fluid handling, applications of membrane technologies, and incorporation of biocompatible materials.
Collaborate with cross-functional teams to translate clinical needs into product requirements and technical specifications.
Perform risk assessments, design reviews, and failure mode analyses (FMEA) throughout the development lifecycle.
Ensure compliance with relevant standards and regulations (e.g., ISO 13485, IEC 60601, FDA 21 CFR Part 820).
Document all design and development activities in accordance with quality management system requirements.
Interface with suppliers, manufacturing, and quality assurance to support design transfer and scale-up activities.
Contribute to intellectual property development through invention disclosures and patent support.
Required Qualifications:
Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
Minimum of 5 years of experience in medical device development, ideally with a focus on renal therapies such as dialysis or extracorporeal flow systems.
Strong understanding of medical device regulations and design controls.
Hands-on experience with CAD (e.g., AutoDesk/Fusion), prototyping, and bench testing.
Familiarity with fluid dynamics, pressure/flow measurement, and blood-contacting materials.
Strong problem-solving skills and attention to detail.
Excellent communication and collaboration abilities.
Preferred Qualifications:
Experience working in a regulated environment (FDA, EU MDR).
Knowledge of dialysis machine systems or related disposable devices.
Why Join Us?
Work on meaningful technologies that improve and save lives.
Join a supportive, forward-thinking team committed to excellence and innovation.
Competitive salary, benefits, and professional development opportunities.
To Apply:
Please submit your resume and a brief cover letter highlighting your relevant experience and interest in the role.
