Sustaining 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 make an impact on the future of healthcare.

The Sustaining Engineer responsibilities play a crucial role that ensures the ongoing engineering and technical support that follows release of requirements, specifications, and drawings for fabrication, assembly, testing, and delivery of an end-product.

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 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.

• Manufacturing:

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

  • Review manufacturing for potential safety hazards and ensure that Safety is engineered into production and quality processes through various safety tools such as, Job Safety Analysis & Safety pFMEAs.

  • Uses Lean/Six Sigma DMAIC Methodology to identify, validate, and implement cost reductions within manufacturing processes through participation & support of the ESAB Business Excellence Performance Management Process (EBX).

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

  • Tracks & Reports for management on capital expenditure. Identifies important assets and tracks effectiveness. Builds business cases by identifying and calculating value of assets and identifies new assets for potential acquisition - based on practicality and profitability.

  • Experience in a product engineering work environment. including, but not limited to, product design, testing, detailed drawings, and use of document release systems.

  • Strong familiarity with IQ/OQ/PQ, with exceptional commitment to detail and documentation.

  • Research new technologies and methods and apply them as needed. 9. Hands-on build-up of concept prototypes for design review and functional proof-of-concept verification and testing.

• Quality Assurance:

  • 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.

  • Conduct design reviews with cross-functional and management participation

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

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

• 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, or sustaining engineering in Class I and II US FDA.

• 5 years' experience in a manufacturing environment

• Electrical hardware development/manufacturing background.

• AutoCAD and SolidWorks proficiency required.

• Able to use statistical analysis software in Excel and Minitab

• Experience with ERP business system experience.

• Epicor preferred.

• Bachelors' Degree in Design, Mechanical Engineering, or related engineering discipline required

• Lean / Six Sigma Green Belt Certification Strongly Preferred. c. Language

• Spanish preferred

Equal Employment Opportunity (EEO)
As an equal opportunity employer, we do not discriminate against any associate or applicant for employment because of sex, color, race, ethnicity, sexual orientation, gender identity, physical or mental disability, age, pregnancy (including childbirth, lactation, and related medical conditions), religion, military/veteran status, national origin, marital status, family or caregiver responsibilities, or any other characteristic or status protected by law.

Pay range: $93,216 - $108,593

Benefits: https://www.ohiomedical.com/contact-us/careers/

Pay Range: