R&D Engineer

Job title: R&D Engineer

Job Document #: JOB-0078 R02

Department: Research & Development

Duties and Responsibilities: Assist in the development of new products from concept generation through commercialization using design and development systems in accordance with FDA and international regulations.

• Work independently to plan, execute, and document small projects and/or portions of larger projects.
• Collaborate with interdisciplinary teams, including quality assurance, regulatory affairs, and manufacturing, to ensure smooth transition from product concept to production.
• Design, build and test functional prototypes to demonstrate proof of concept in bench testing and animal studies.
• Lead design verification and validation activities, including planning, manufacturing, and generating test protocols and test reports.
• Develop, qualify, and validate new manufacturing processes and/or test methods.
• Assist in and/or lead the preparation and review of technical documents, including design inputs, risk management documents, test protocols, and reports.
• Interact with marketing department and customers (ie, physicians) to identify and document new product requirements according to user and clinical needs.
• Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services.
• Prepare and maintain detailed design and process documentation in accordance with internal procedures and U.S. and international regulatory requirements.
• Stay current with the latest developments in the clinical field and contribute innovative ideas for new products or improvements to existing products.

Qualifications

Education & Certifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.

Work Experience:

• 3-5 years experience in a medical device R&D environment is required.
• Basic understanding of FDA regulations and ISO standards related to medical device development is preferred.

Knowledge, Skills & Abilities:

• Able to read, write and understand English.

• Proven problem-solving abilities, analytical thinking, and attention to detail.
• Proficiency in 3D CAD software, such as SolidWorks or AutoCAD.

• Experience with design controls and risk management within a regulated industry is a plus.

Physical Requirements:

• Must be able to work in an office and lab/cleanroom environment. Some travel may be required for vendor visits or conferences.
• Location: Westminster, Colorado

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