Myra Vision, a Shifamed Portfolio Company, is developing a treatment that safely and effectively reduces high intraocular pressure (IOP) for moderate to severe glaucoma patients. More than one third of glaucoma patients have moderate to severe disease, which requires significant reductions in IOP to reduce the risk of vision loss. To learn more about Myra Vision, please visit https://www.myravision.com/. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description The Sr./Staff Process Development Engineer contributes to medical device product design, process development, manufacturing, and testing in accordance with the company's Quality System. This role will partner with internal and external stakeholders to strategically develop capable and scalable processes necessary to support successful product launch. Generate process requirements and outputs through interface with cross-functional team members. Contribute both individually and as part of a cross-functional product development team. This is a full time on-site position and will require reporting to our offices located in Campbell, CA. Responsibilities, Skills & Hands-On Experience * Develop mechanical aspects of manufacturing processes by applying engineering knowledge and product design, fabrication, assembly, tooling and materials * Perform process optimization and manufacturing scale-up; develop and implement ergonomic improvements to the process. * Design and validate fixtures and tools for manufacturing and inspection processes and optimize to reduce requirements for operator skill. * Research, develop, modify, and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R. * Improve manufacturing efficiency through planning and evaluation of workflow, space requirements and equipment layout. * Provide day-to-day manufacturing support and decision-making; troubleshoot assembly process issues as necessary; respond with urgency to process and equipment issues. * Assure product and process quality by designing test methods, performing process validations and process capability studies. * Establish manufacturing and inspection procedures; prepare process validation protocols and reports; execute process validations; collect and analyze process data and trends and implement changes. * Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.). * Provide training to associates, technicians and operators, assisting other technical associates. * Design, execute, and analyze experiments using sound statistical methodology. Participate in risk management activities, including development and ownership of process FMEAs. * Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation. * Support product verification and validation activities by developing test protocols and writing test reports. * Support company goals and objectives, policies and procedures, and regulatory requirements (FDA regulations, ISO 13485, MDD, etc.). * Represent Myra Vision as the technical lead with external manufacturing partners. * Lead and Mentor other Engineers. * May require occasional domestic travel. Education & Work Experience * Bachelor's in Mechanical Engineering, Industrial Engineering, Material Science or equivalent experience. * 5 - 7 years of previous medical device experience or equivalent experience in similar industries. * Preferred: Experience developing processes associated with shape memory alloy, nitinol. * Experience developing and executing process and/or equipment validations. * Proven ability to prioritize, initiate, and drive projects to completion. * Experience with quality system documentation requirements and test protocols. * Experience in SolidWorks. * Understanding and exposure to principles of product design, manufacturing, risk analysis, and product testing/reporting. * Demonstrated ability to apply engineering fundamentals and statistical analysis to manufacturing process trending, improvement, and troubleshooting. * Familiarity with FDA QSR, ISO 13485, and the MDD. * Excellent communication skills; ability to work independently or in project team setting. Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits. NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [email protected].