Site location: South Denver/Colorado Springs
Reports to: R&D Director
Base Salary: 80-130K
This R&D Engineer will be assisting in the development of medical devices for use in various types of surgeries. The position plays a critical role in conceiving and developing innovative products and advancing them through the product lifecycle. The primary responsibilities of this role include supporting all phases of device development, in particular the identification and evaluation of design options, the definition of product and performance specifications, and design verification and validation activities. Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the DHF.
• Constructing of proof-of-concept prototypes to prove performance and de-risk future project activities.
• Developing product assembly documentation as required
• Building finished devices for design development and verification as part of the development process
• Contributes to product development projects and/or technology development efforts.
• Involved in all aspects of product development activities and product Design History Files, such as: requirements creation, documentation, ideation, prototyping, design/development documentation, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
• Supports or leads efforts to evaluate and identify design solutions which meet product/performance requirements, cost targets, and manufacturability requirements.
• Authors product verification testing protocols and reports and ensures products meet/exceed established specifications.
• Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
• Supports in ensuring product and performance specifications are appropriate and accurate.
• Supports internal and external suppliers and manufacturers as needed. Including external design and/or development partners.
• Bachelor’s degree in engineering (Biomedical or equivalent preferred).
• 2-15 years Engineering experience, life science industry background a must
• Ideation & prototyping
• CAD design /development documentation
• technical risk mitigation
• verification testing and reports
• design validation studies
• risk management documentation
• design reviews