The Product Design Engineer III will support the Business Development R&D department. The engineer is responsible for developing and implementing new products, changes to on-market products, and DHF support documentation of products through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is to design, develop, and improve ICU's product portfolio to ensure their efficiency and reliability. The incumbent will be heavily involved with plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The R&D Product Engineer will be expected to interface mainly with internal customers and external suppliers on the design and configuration of high-volume disposable medical devices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. The position requires the ability to interact with multiple functional groups such as Marketing, Regulatory, Quality, Operations, etc.
Essential Duties & Responsibilities
Assist in the development of products from concept to production
Develop product requirements according to customer and business needs in compliance with international standards and regulations applicable.
Adhere to established design control processes and good engineering practices
Design and model components and devices for various product lines using SolidWorks
Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines
Provides technical support on components, material methods, systems and equipment
Provides the technical foundation for the development of risk documentation
Develops test procedures to ensure specifications and regulations are met
Writes, reviews, and approves protocols, reports and data
Conducts testing outlined in protocols and test methods
Executes engineering and validation studies on products
Conducts failure investigations
• Work on special projects as assigned
Knowledge & Skills
Detail oriented and ability to organize large amounts of work and data.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, time management, professionalism, coaching, influencing, and team building.
Knowledge of medical device manufacturing practices
Knowledge of medical grade plastics and general injection molding principles
Strong knowledge in joining methods of plastics
Experience with design of experiments (DOE) and basic statistical methods
Excellent project leadership and ability to expedite project completion
SolidWorks competency required
Understanding of engineering mechanics and physics
Familiarity with machine shop practices
Familiarity of drafting standards
Minimum Qualifications, Education & Experience
• Must be at least 18 years of age
Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.
4+ years of experience in Medical Device Product Development or related field
Work Environment
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time
Salary Range: 88,000-126,500k
The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.