Design Engineer

Job Description:

Ohio Medical is a global leader in medical air and vacuum pumping systems, suction, and oxygen therapy devices. Our trusted brands, including Ohio Medical and Amvex, offer cutting-edge solutions such as suction regulators, air and oxygen flow meters, pumping systems, and portable suction equipment. Operating in an FDA-regulated facility, we adhere to ISO 13485, ISO 9001, and NFPA 99 standards, ensuring high-quality and reliable products that meet global regulatory requirements. Headquartered in Gurnee, IL, we take pride in our commitment to patient safety, innovation, and quality products.

With a history dating back over 100 years, Ohio Medical has shaped the medical industry. In 1910, we manufactured one of the first anesthesia gas machines, The Ohio Monovalve, which was extensively used during World War I. Our legacy includes innovations such as the Push-To-Set (PTS) suction regulator and advancements in medical gas and oxygen therapy. In 2022, Ohio Medical joined The ESAB Corporation, furthering our mission to deliver innovative, high-quality products that prioritize patient safety. Join a team where history meets innovation and makes an impact on the future of healthcare.

A Medical Device Design Engineer reviews Ohio Medicals medical device designs and seeks ways to improve process and product performance while ensuring performance standards and regulatory requirements are met. They collaborate with various teams, including product managers, clinicians, and regulatory affairs, to translate medical needs into functional and innovative devices. This role involves tasks like CAD modeling, prototyping, testing, and documentation, while also adhering to industry standards and regulations

Reporting to the Director of Operations, the primary role of this position is to support commercial products by providing technical expertise and ownership of product design and supplier manufacturing changes to ensure supply continuity and quality system requirements. This role works within a broader team of Supply Chain, Quality, and Regulatory to maintain products through ongoing improvements and focused initiatives to improve employee processes and patient experiences. Ohio Medical is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

• Responsible for having a strong understanding of design and manufacturing principles, with the ability to specify, design, verify, and validate medical device design changes post-market. 2. Use of experimental, empirical, and numerical analyses to evaluate designs, perform engineering analysis with simulation tools to mitigate design risks, and ensure new design reliability

• Develop and implement design and manufacturing processes to ensure the delivery of high quality medical devices.

• Leads root cause investigations, resolves customer complaints, and collaborates with cross functional teams to drive compliance with FDA regulations and ISO 13485 standards

• Conduct feasibility studies, design verification testing, and risk analysis to ensure product safety and reliability.

• Responsible for CAD modeling, manufacturing feasibility, and design for assembly.

• Supports manufacturing as a Subject Matter Expert & Technical Resource by performing engineering activities including troubleshooting, studies, and root cause analysis and takes initiative to implement effective actions to reduce the occurrence/recurrence of the problem/ nonconformance.

• Understanding and use of engineering tools such as FMEAs, statistical engineering techniques, Design of Experiments, and product capability analysis.

• Hands-on build-up of concept prototypes for design review and functional proof-of-concept verification and testing.

• Demonstrates commitment to Change Control Process with an appreciation of change impacts.

• Participates and, at times, leads investigations of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations.

• Ability to diligently advance and support projects under regulatory oversight by FDA, and other Notified Bodies.

• Familiarity with labeling requirements, including but not limited to FDA UDI. 14. Research new technologies and methods and apply them as needed.

• Works with a broader team of Supply Chain, Quality, and Regulatory to maintain products through ongoing improvements and focused initiatives to improve user experience, process and employee productivity.

• Leads & participates in Reviews of specifications of dimensional, material, and functional characteristics of mechanical parts with non-conformances for disposition.

• Participates and contributes to Preventative Maintenance Program for Med-Device and Med Gas divisions.

• Other duties that are outside of the scope of this job description may be assigned as needed by the manager.

• 5 years engineering experience with a minimum of 3 years' experience with medical devices, product / process development in Class I and II US FDA.

• 5 years experience in a manufacturing environment Electrical hardware development/manufacturing background.

• AutoCAD and SolidWorks proficiency required.

• ANSYS Design/Simulation Software Highly preferred.

• Able to use statistical analysis software in Excel and Minitab

• Experience with ERP business system experience.

• Epicor preferred.

• Bachelors Degree Required

• Field Design or Mechanical Engineering or related engineering discipline

• Lean / Six Sigma Green Belt Certification Strongly Preferred.

• English required, Spanish preferred

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time. Ohio Medical is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law

View our Benefits: Ohio Medical

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