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Gurnee, Illinois, USA, United States of America
Onsite
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 primary objective of the position is product development from verification of the viability of products with market and customers through product transfer to launch production through end of life. The position serves as Technical Lead for products ranging from material and product design, new product development, regulatory updates, and product improvements. The position plans, schedules and leads the evaluation, selection and adaptation of various materials, components, test methods, engineering techniques, and procedures with minimal guidance.
Product development and modification of Suction and Oxygen Therapy products to established design control processes and good engineering practices.
Lead product development from concept through various stages of prototyping to final design by applying sound engineering principles including identification of product requirements, concept design and selection, prototyping, testing, etc. Responsible for material selection, part and product design, design verification, and design transfer to manufacturing.
Interface with customers and suppliers on medical device design requirements.
Work closely with internal Ohio Medical functions (Sales, Marketing, Quality, Regulatory, Production and Purchasing) to provide technical expertise, develop design solutions, and introduce new products and product enhancements that meet customer business regulatory requirements.
Design for manufacturability through collaboration with Industrial and Manufacturing Engineering. Assist with development of assembly work instructions and training of production personnel to ensure product design, performance and quality requirements are met.
Perform new product design verification testing and design transfer working with Quality and Manufacturing engineering. Prepare and execute engineering studies, design verification, and validation protocols.
Generate technical documentation for design control history files and product technical files.
Responsible for usability engineering and risk management.
Lead design improvements of existing products for improved performance and/or cost, ensuring compatibility with design requirements through appropriate verification testing. • Assist with CAPA investigations and implementation.
Work with Product Manager to develop and manage project schedules that include cross-functional teams of technical support groups, to meet deliverables and commitments. Organize project plans and manage projects to completion by monitoring project progress, coordinating activities, resolving conflicts, and periodically reporting on project status to management.
Create component part drawings, assembly drawings, and solid models of parts and assemblies (Solid Works). Organize and maintain digital files. Release and revise documents and drawings through established engineering change control process.
Create and maintain part data and assembly BOM and MOM data in company’s ERP system (Epicor).
Work directly with OEM customer engineering teams to establish product design requirements and assure adherence to those requirements.
Understand international product standards and regulatory requirements to verify that design and labelling elements meet requirements. Perform technical reviews of product literature, manuals, and promotional materials.
Responsible for product label creation, assuring that requirements are met with input from Marketing and Regulatory Affairs.
Perform duties and tasks as prescribed by company policies, standard operating procedures, and work instructions.
3 – 5 years’ experience in product design and development in a regulated industry
Medical device design experience preferred.
Experience working with cross-functional project teams.
Working knowledge of CAD software, Solid Works experience preferred.
Familiarity with design and material selection for various manufacturing processes: (injection molding, die cast, machining, sheet metal forming, etc)
Working knowledge of design control process as well as FMEA and Risk Analysis
Working knowledge of compliance to standards and regulations
Experience using stage-gate process for new product development.
Experience using Design for Manufacture and Assembly (DFMA) to simplify the product assembly and estimate component/product costs.
Bachelor’s degree in mechanical engineering or equivalent experience
Team-oriented individual with strong interpersonal skills
Ability to challenge ideas, philosophies, colleagues, and status quo to lead an environment of continuous improvement.
Proficient using Solid Works to create detailed drawings of parts and assemblies.
Proficient computer skills, including Microsoft Office Suite and Outlook
Accurate and precise attention to detail
Creative and innovative thinker and planner
Ability to multitask, prioritize, and manage time efficiently.
Ability to apply statistical and engineering techniques to solve complex problems.
Ability to effectively operate within, and facilitate, cross functional teams with minimal guidance.
Excellent writing and communication skills. Ability to present and communicate results and recommendations to project teams and decision makers.
Knowledge of hand tools, machinery, and electrical test equipment
Knowledge of regulatory requirements related to medical devices.
Learn about our benefits here: Ohio Medical Employee Benefits
Pay Range:
$84,872.00-$98,354.00