Senior Process Development Engineer
2 weeks ago
We are seeking a highly skilled Process Development Engineer to join our team at Bolt Medical. As a key member of our engineering team, you will be responsible for designing, developing, and optimizing manufacturing processes to ensure efficient and high-quality production.
Key Responsibilities- Evaluate current manufacturing practices and identify areas for improvement.
- Lead process development and optimization activities with a focus on Design for Manufacturing.
- Collaborate with R&D and Manufacturing teams to ensure seamless integration.
- Draft design transfer documentation for multiple production lines.
- Analyze and design process workflows to improve efficiency and maximize production capacity.
- Apply Lean Manufacturing Methodology and Six Sigma tools to drive process improvements.
- Develop and implement manufacturing process development, implementation, and continuous improvement strategies to enhance yield, reduce cost, and operator dependency.
- Represent Process Engineering in R&D and Project Team meetings and provide technical expertise and support.
- Perform or manage process validations and troubleshoot production line issues.
- Lead scaling up processes from development to full-scale manufacturing.
- Bachelor's degree in a scientific or engineering discipline.
- Minimum 5 years of experience in medical device manufacturing, preferably with catheter experience.
- Minimum 5 years of Process Engineering experience.
- Working knowledge of mechanical design principles and FDA regulated medical device design controls.
- Proficient in CAD software, preferably SolidWorks.
- Statistical analysis of raw data and proficiency in Minitab are required.
- Hands-on experience managing suppliers and/or contract manufacturers is a plus.
- Familiarity with design control according to 21 CFR 820 or ISO 13485 is preferred.
- Proficient in Risk Management according to ISO 14971.
- Knowledge of ASME Y14.5 GD&T.
- Excellent interpersonal, communication, and documentation skills.
- Takes initiative and acts quickly to drive solutions.
- Strong interpersonal, organizational, and communication skills.
- A flexible team player with a positive results-oriented attitude.
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Senior Process Development Engineer
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