Manufacturing Engineer II/Sr.

Renata Medical is a fast-paced startup focused on developing and commercializing novel pediatric medical devices. We are passionate about delivering innovative solutions that improve the lives of our patients. Join our mission-driven team and help us bring life-changing products from concept to reality.Position OverviewWe are seeking a motivated and experienced Senior Manufacturing Engineer to take ownership of manufacturing processes and play a critical role in developing new products and scaling production for commercial production lines. This individual will be responsible for applying Design for Manufacturability (DFM) principles, driving continuous improvement, and ensuring a reliable supply of high-quality products.This role requires a hands-on engineer who thrives in a dynamic startup environment, collaborates cross-functionally, and is passionate about building robust, scalable manufacturing processes.Key ResponsibilitiesLead the development, validation, and qualification of new manufacturing lines for pediatric medical devices.Sustain and scale manufacturing activities for commercial products.Conduct thorough root cause analyses and drive timely resolution of yield, quality, and development issues.Apply DFM principles to influence product design and ensure manufacturability.Write clear, detailed technical work instructions and train operations staff on assembly processes.Design and implement robust and mistake-proofed manufacturing fixtures and line setups.Manage day-to-day production activities and support operations as needed.Collaborate closely with R&D, Quality, and Operations to develop and sustain efficient manufacturing processes.Champion continuous improvement initiatives to enhance product quality, reduce waste, and increase throughput.Maintain compliance with medical device quality systems and regulatory requirements.QualificationsBachelor's degree in engineering or related field.3+ years of experience in medical device manufacturing; Class III and catheter-based device experience preferred.Proven experience in process development, sustaining engineering, and lean manufacturing.Strong analytical and problem-solving skills with a methodical approach to root cause analysis.CAD skills for fixture design (e.g., Creo, SolidWorks, or equivalent).Demonstrated ability to train and lead technicians and operators.Experience with manufacturing line development and/or transfers.Excellent written and verbal communication skills.Strong organizational skills and ability to navigate complex manufacturing logistics.Ability to work independently and collaboratively in a fast-paced, evolving environment.Significant experience and knowledge of medical device quality systems and design controls.BenefitsFull benefits package, including 401(k) and voluntary benefits.Competitive compensation, including bonuses and equity.Fast-paced start up culture with opportunities for career advancement.