Senior Design Engineer - Medical Devices

About Contraline Inc. Contraline is a venture-backed medical device company based in Charlottesville, Virginia. The company's lead product is ADAM â„¢ , the world's first injectable hydrogel designed to provide long-lasting, non-hormonal, and reversible contraception for men. The company aims to use its hydrogel platform technology to address global reproductive health challenges that have no solutions and large unmet needs. About the role The Sr. Design Engineer is responsible for designing and developing Class II and Class III medical devices. This position requires strong analytical and technical skills and adherence to Quality System Regulations. The Sr. Design Engineer should be able to work independently and within teams, serving as a technical lead. This is a full-time, on-site position and reports to the Director of Engineering and Product Transfer. What you'll do Development of novel polymer-based implantable devices and surgical tools from ideation through design development and manufacturing consistent with Medical Devices Regulatory and Quality requirements. Manage prototype and pilot builds of devices, including inspection and characterization. Create and implement plans for product verification and process validation, as well as FMEAs. Lead and create documentation for design reviews including technical prints following GD&T guidelines, test reports including sampling statistics, tolerance analyses, and new design input requirements based on risk management activities. Create and analyze technical data, create protocols and reports, as well as presentations to internal and external stakeholders. Come up with innovative designs for optimized clinical performance and user-friendly procedure using Human Factors Engineering (HFE). Generate new ideas for research products/programs, opportunities, and intellectual property. Manage relevant component vendor relationships, manufacturing partners, and external testing. Qualifications A Bachelor's degree in mechanical or biomedical engineering with at least 4 years of industry experience or a Master degree with at least 3 years of industry experience. Significant experience in the design and development of Class II and Class III medical devices, including experience/exposure to manufacturing and product release testing of medical devices. Experience and knowledge of FDA CFR 21, Part 820, ISO 13485, ISO 14971, ISO 10993 standards as well as GMP and GLP. Experience in generating product requirements, test method validation, design verification, process validation, and risk analysis. Experience in Design for Manufacturability (DFM) is preferred. Proficiency with CAD (Solidworks or Fusion 360 preferred). Knowledge of geometric dimensioning and tolerances. Knowledge of statistical tools and ability to apply them in data analysis as well as sampling strategies. Basic knowledge of biomaterials and polymer processing. Applicants must be authorized to work in the United States. Contraline is a Charlottesville-based company working at the forefront of reproductive medicine. We believe that we go further when we go together. We are dedicated to building a diverse, inclusive and authentic workplace. If you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. All backgrounds, identities, and voices are welcomed!

Created: 2024-11-01