Company Description
Maxtec is a leading innovator of products for respiratory care, specializing in oxygen sensors and analyzers. Medical professionals and patients value Maxtec’s variety of products for their quality and accuracy. We are a worldwide leader in the manufacturing of oxygen sensing, delivery, and analysis equipment.
Maxtec continues to pursue excellence in the development of new products, committing to the principle that oxygen must be measured with the utmost accuracy. We strive to continue to produce better methods of measuring oxygen and protecting patients worldwide.
Maxtec was awarded the "Best Place to Work" at the ChamberWest 2020 Awards Gala and we can't agree more! Come join us in making a positive impact in the world around us.

Job Description
The Medical Device Engineer for Maxtec will play a key role as part of our Design Engineering team, responsible for new product development and sustaining the existing product portfolio. We are seeking a talented, high-performing individual with a passion for creating solutions that improve lives. The ideal candidate will be experienced with the development process in the highly-regulated medical device industry and have a strong working knowledge of both domestic and international regulations that govern this space.
RESPONSIBILITIES, ACCOUNTABILITY, TASKS, AND DUTIES

• Lead product development initiatives from concept to production release through a controlled design development process
• Lead cross-functional product design reviews
• Collaborate with vendors to source and specify materials, processes, tooling or supplies for product manufacturing
• Generate new designs and drawings via SolidWorks
• Develop and execute testing and design verification/validation protocols for new products, processes, or equipment at various stages of development
• Utilize statistical methods as required to plan testing and to analyze test results
• Coordinate product transfer and production ramp up with operations to include validation and related documentation and training
• Maintain Design History Files and Technical Files
• Update design files as needed to maintain compliance with evolving regulations and standards
• Work with marketing and sales to define and refine design inputs, generate design concepts and prototypes independently
• Conduct risk analysis activities and complete required documentation
• Identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements

AUTHORITY

• Authorized to sign all documents requiring Engineering approval as defined in the design control, document change and quality system procedures

Qualifications

• Minimum 2 years of experience in medical devices
• Experience with EU MDR strongly preferred

REQUIRED EDUCATION, COMPETENCE, TRAINING AND KNOWLEDGE

• Bachelor's Degree in Mechanical, Biomedical Engineering, or equivalent technical field
• SolidWorks or equivalent CAD experience
• Strong written and verbal communication skills and proven ability to present information to internal and external stakeholders
• Strong analytical skills and comfort with learning new technologies, systems, and applications
• Strong and proven problem-solving skills
• Computer proficiency in Microsoft Office products (Excel, PowerPoint, Word, etc.)
• Diverse background in fabrication techniques including, but not limited to, injection molding, thermoforming, machining, and extrusion preferred

Salary range $80,000 - $110,000 DOE

Additional Information
All your information will be kept confidential according to EEO guidelines.

Job Type: Full-time

Pay: $80,000.00 - $110,000.00 per year

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