Job Summary: Biomotum is a rehabilitation robotics company searching for a Mechanical Design Engineer to help develop our wearable robotic assistance medical devices. Our goal is to transform the treatment of movement disorders to improve the lives of people all over the world. The successful candidate will work with a team of engineers and external partners to bring our assistive technology to the market. Responsibilities: - Partner with teammates to establish user and product requirements (e.g., user needs, design inputs, and design outputs) and design, develop, and test electro-mechanical systems in partnership with internal and external teammates. - Create technical architecture, engineering designs, physical prototypes, and documentation to effectively communicate concepts/designs to manufacturers and teammates. - Develop, plan, perform, and document design verification and validation testing. - Utilize graphical, mathematical, and other appropriate communication methodologies to share results & make recommendations for product and process improvements. - Establish and maintain Device Records and Design History Files. - Participate in root cause analysis investigations and reporting in support of Corrective and Preventative Actions (CAPAs), complaints, and nonconformances. - Plan and complete product risk management activities (e.g., risk identification, assessment, and mitigation) with the goals of reducing patient risk as far as possible and ensuring product benefits outweigh patient risk. - Develop, plan, implement, and document medical device usability activities (e.g., user interface specification development, summative evaluations) with the goal of creating a safe device that can be used without use errors that result in significant patient risk. - Evaluate effectiveness, manufacturability, reliability, safety, and cost of product and process designs. Interface with and oversee part and subassembly suppliers. - Assist with sustaining engineering efforts for products with current customers. - Clearly document manufacturing and servicing work instructions & train technicians. - Attain and maintain training to Quality Management System (QMS) requirements. What you will need: - General design/engineering and knowledge - able to communicate effectively and understand how technical teams' tasks fit together. - A desire to find a solution to problems and create the greatest product for Biomotum's customers. - A first-principles, systems-thinking approach to finding solutions to problems. - A strong desire to work as a team. Qualifications: - B.S. in Biomedical or Mechanical Engineering (or related field). - Experience implementing structured root cause analyses. - Experience creating scientifically valid experimental design and performing statistical assessment. - Minimum 2 years experience working in a regulated industry (e.g., medical devices, pharmaceutical, aerospace). - Demonstrated knowledge of and experience applying requirements of 21 CFR 820, ISO 14971, IEC 62366-1, and ISO 13485 and tor the development of medical devices preferred. - Experience in Solid Works part design and assemblies. - Propensity to proactively prioritize, initiate, and drive your own work to meet established timelines and business goals. - Knowledge of how to apply engineering fundamentals and statistical assessment to ensure product quality, reliability and patient safety. - Excellent written and oral communication. - Experience creating documentation that is acceptable to regulatory agencies. Travel: Up to 20% travel may be required Location: Portland, Oregon (this not a remote position) Compensation: Salary and equity compensation is commensurate with experience. Commitment to Diversity: We welcome candidates from all backgrounds, beliefs, and identities to contribute to building a diverse, respectful, collaborative and inclusive environment. Employment Type Full-time https://www.linkedin.com/jobs/view/3362901751/?refId=FE6%2F1%2F8RwKmuEvK7ZP0... Josefine Fleetwood, (she/her) Employer Relations Manager Oregon State University | College of Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood@oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu> [cid:image001.jpg@01D8FDCA.D4A5B3C0]
