Senior Manufacturing Engineer (Medical Device Industry - LOCAL CANDIDATES ONLY)

New Product Introduction & Process Development

• 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 contracts and OEM manufacturing solutions.

Process Optimization & Continuous Improvement

• Utilize Lean Manufacturing 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.

Fixture, Tooling & Equipment Development

• Specify, select, install, and validate manufacturing tools, fixtures, and automation solutions.
• Support semi-automated and manual assembly processes, integrating scalability and long-term reliability.

Vendor & Supply Chain Management

• 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.

Shop Floor Engagement & Technical Expertise

• Work closely with Production teams to troubleshoot and resolve real-time manufacturing challenges.
• Mentor and provide leadership to Manufacturing Engineers, guiding them in engineering principles and best practices.

Required Qualifications

• Bachelor’s degree in Mechanical or Manufacturing Engineering, or similar, with 5+ years of experience in manufacturing engineering, with a focus on medical device assembly, catheter assembly, and high-volume production, or equivalent education and years of experience.
• Extensive experience in validation protocols (IQ/OQ/PQ), risk mitigation, and regulatory compliance (FDA, ISO 13485, GMP).
• Proficiency in SolidWorks and tolerance stack-up analysis.
• Comfortable working directly with production teams.
• Demonstrated experience in cross-functional team support within medical device manufacturing.
• Background in vendor management, outsourcing, and supplier qualifications.
• Excellent communicator and collaborator who enjoys working across teams.
• Strong attention to detail and a proactive, solutions-oriented mindset.
• Organized and capable of juggling multiple priorities in a fast-moving startup.
• Have a high degree of integrity, accountability, and a passion for doing things the right way.

Nice to Have

• Prior startup or early-stage company experience.
• Familiarity with Microsoft Teams.

Physical Requirements

• Ability to lift up to 25 lbs.
• Able to work extended periods sitting or standing based on project needs.