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 Overview

We 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 Responsibilities

• Lead 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.

Qualifications

• Bachelor’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.

Benefits

• Full benefits package, including 401(k) and voluntary benefits.
• Competitive compensation, including bonuses and equity.
• Fast-paced start up culture with opportunities for career advancement.