About the position
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. We are seeking an experienced Senior Manufacturing Engineer II to drive the scalability, efficiency, and reliability of our medical device manufacturing processes. This role will focus on transitioning new and evolving product lines into high-volume production while ensuring compliance with industry standards, process optimization, and manufacturability. The ideal candidate will be hands-on, shop-floor oriented, and capable of working cross-functionally with production, R&D, quality, regulatory, and suppliers to implement best-in-class engineering solutions. This is a dynamic role for an engineer who thrives in a fast-paced manufacturing environment and is passionate about driving innovation, efficiency, and quality in medical device production. If you are a technical leader with a proven track record in manufacturing excellence, we encourage you to apply!
Responsibilities
- Provide operations leadership to new product development teams, ensuring manufacturability and cost-effective global sourcing.
- Lead the transition of non-mature product lines into scalable, high-efficiency manufacturing processes.
- Conduct Design for Manufacturability (DFM) and Design for Assembly (DFA) reviews to optimize product designs for production.
- Develop and refine assembly workflows, fixtures, and equipment to improve repeatability, throughput, and yield.
- Establish and execute validation strategies (IQ/OQ/PQ) for new products, processes, and equipment in compliance with ISO 13485 and FDA regulations.
- Identify and engage with vendors to develop contract and OEM manufacturing solutions.
- Utilize Lean Manufacturing and Six Sigma (DMAIIC) methodologies to eliminate inefficiencies and enhance production yield.
- Implement data-driven problem-solving techniques, such as root cause analysis and risk mitigation strategies.
- Optimize workstation layouts, assembly line flow, and ergonomic considerations to improve operator efficiency.
- Research, recommend, and implement new technologies and manufacturing methods to enhance operational performance.
- Design and develop high-precision fixtures and electro-mechanical equipment for high-volume manufacturing.
- Specify, select, install, and validate manufacturing tools, fixtures, and automation solutions.
- Ensure all tools and equipment maintain performance integrity over thousands of cycles.
- Support semi-automated and manual assembly processes, integrating scalability and long-term reliability.
- Assess and manage vendors to ensure components and finished goods meet technical and quality standards.
- Develop global, cost-effective manufacturing strategies through contract and OEM relationships.
- Evaluate supplier capabilities and implement vendor partnerships with Purchasing and Quality teams to ensure optimal performance.
- Serve as a technical authority on machining techniques, GD&T, and mechanical design best practices.
- Work closely with production teams to troubleshoot and resolve real-time manufacturing challenges.
- Provide expert-level guidance on precision machining, tooling, and process control.
- Mentor and provide leadership to Assistant and Associate Engineers, guiding them in engineering principles and best practices.
Requirements
- Bachelor’s degree in mechanical or manufacturing engineering, or similar, with 8+ years of experience in manufacturing engineering, with a focus on medical device assembly and high-volume production, or equivalent education and years of experience.
- Master’s degree in mechanical or manufacturing engineering, or similar, with 5+ years of experience in manufacturing engineering, with a focus on medical device assembly and high-volume production, or equivalent education and years of experience.
- Doctoral degree in Mechanical or Manufacturing Engineering, or similar, with 3+ years of experience in manufacturing engineering, with a focus on medical device assembly and high-volume production, or equivalent education and years of experience.
- Strong expertise in product design for complex assemblies, with advanced knowledge of medical-grade metals and polymers.
- Extensive experience in validation protocols (IQ/OQ/PQ), risk mitigation, and regulatory compliance (FDA, ISO 13485, GMP).
- Proficiency in SolidWorks, GD&T, and tolerance stack-up analysis.
- Hands-on, shop-floor mentality—comfortable working directly with production teams.
- Demonstrated experience in cross-functional project management within medical device manufacturing.
- Strong background in vendor management, outsourcing, and supplier qualification.
Nice-to-haves
- Experience developing semi-automated manufacturing equipment and integrating automation solutions.
- Familiarity with optics, cameras, cautery systems, and electrical assemblies.
- Experience with neuro-related medical devices and electro-mechanical systems.
- Process Excellence Black Belt or equivalent certification, with a track record of applying Lean/Six Sigma techniques and progress toward Master Black Belt certification in Process Excellence.
