Senior Manufacturing Engineer
About The Position
The Senior Manufacturing Engineer oversees Instylla’s manufacturing engineering efforts for vascular embolic technologies and associated devices. The role ensures product quality and scalability, drives continuous improvement, and supports the company’s long-term growth. The engineer develops operational strategies aligned with business objectives, serves as a subject matter expert in manufacturing technologies and methods, and supports efficient, compliant medical device production. The position manages manufacturing-process optimization and value-improvement initiatives, uses data analytics to track performance and drive improvements, and identifies ways to reduce production costs while maintaining quality. It leads root cause analysis and corrective actions for production issues, defects, customer complaints, and other technical challenges, as well as sustaining engineering work involving vendor changes, supply-chain shifts, and component obsolescence. The role also manages engineering projects, budgets, and resources; provides leadership, mentorship, and training; maintains regulatory compliance; and fosters collaboration, innovation, and continuous learning. May be required to supervise Manufacturing Engineers and Technicians.
Requirements
- Bachelor’s degree in manufacturing engineering, biomedical engineering, or another engineering discipline.
- At least 7 years of manufacturing engineering experience in the medical device industry.
- At least 2 years of supervisory experience.
- In-depth knowledge of FDA regulations, ISO standards, and relevant industry guidelines.
- Expertise in manufacturing methodologies including LEAN, Six Sigma, CAPA, SPC, and other problem-solving methods.
- Experience with Minitab or other statistical evaluation software.
- Experience scaling operations during organizational growth.
- Proven track record leading transformational change initiatives.
- Strong understanding of regulatory impacts on processes and alignment between functional operations and business strategy.
- CAD experience.
- Collaborative approach and a track record of building cross-functional partnerships.
Nice To Haves
- Master’s degree or other advanced degree.
- Experience in device manufacturing for peripheral vascular devices, including implants.
- Experience scaling operations in a start-up environment.
- SolidWorks experience.
Responsibilities
- Develop and implement operational strategies aligned with business objectives to improve product consistency, reliability, and scalability.
- Serve as a subject matter expert on manufacturing technologies, processes, and methodologies.
- Support medical device manufacturing processes to ensure efficient production and compliance with quality standards.
- Optimize manufacturing processes, including value-improvement initiatives.
- Use data analytics to track performance, define metrics, and drive improvements.
- Identify process-optimization and continuous-improvement opportunities that reduce production costs while maintaining quality.
- Lead root cause analysis and corrective actions for production issues, product defects, customer complaints, and other technical challenges.
- Lead sustaining engineering initiatives related to vendor changes, supply-chain shifts, and component obsolescence.
- Manage engineering projects, budgets, and resources to achieve business objectives.
- Provide leadership, mentorship, and training to enhance team capabilities.
- Maintain adherence to FDA, ISO 13485, and other regulatory requirements.
- Foster collaboration, innovation, and continuous learning.
- May supervise Manufacturing Engineers and Technicians.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
