Manufacturing Engineer (Medical Device)

About The Role

We are looking for a Manufacturing Engineer to manage verifications and validations of our devices and software tools. This role will also collaborate internally with cross functional teams and externally with our manufacturing partners to ensure compliance, quality, and efficiency in our manufacturing process, engineering documentation and drawings, design transfers, etc.

We are open to this role being at the Engineer or Lead level based on experience.

What You'll Be Doing

• Lead continuous improvement initiatives to enhance manufacturing efficiency through the development and optimization of tools, processes, and software
• Support manufacturing line setup and optimization at contract manufacturing (CM) partners, including line balancing, cycle-time reduction, and continuous improvement initiatives to increase production efficiency and throughput
• Support make-versus-buy evaluations and, when transitioning manufacturing or packout in-house, help develop and execute the transition plan, including process validation, equipment and resource requirements, and production readiness
• Manage verifications and validations of new products/devices/tools releases
• Generate protocols and SOPs for final testing, handling, and reporting
• Support R&D systems testing
• Conduct systems and software validation
• Support root cause investigations
• Act as the main liaison between Operations, R&D, Product and Regulatory / Quality teams and our external manufacturing partners
• Ensure manufacturing processes and quality criteria meet BioIntelliSense’s standards and that procedures comply with safety and environmental regulations
• Develop and test effective automated and manual systems
• Organize and manage manufacturing workflows and resources
• Collaborate with other engineers, contractors, and suppliers

What We Are Looking For

• Bachelor’s degree in Mechanical, Electrical, BioMedical, Manufacturing, Industrial, or a related engineering discipline
• 3-8 years’ experience in a Manufacturing or Industrial engineering environment with offsite/offshore manufacturing partners
• Medical device manufacturing experience working within a quality management system (ISO 13485, FDA 21 CFR Part 820)
• Experience with verification and validations of medical devices, software/tools, and systems
• Proven ability to perform root cause analysis
• Excellent communication and project management skills
• Knowledge of manufacturing processes, fabrication methods, tool design and quality assurance techniques
• Familiarity with manufacturing equipment and quality assurance technique

Preferred Qualifications

• Master’s degree in Engineering or an MBA
• Demonstrated experience building software tools to drive Lean or efficiency improvements (e.g., Python, SQL, Power BI, Power Apps, or similar), from defining requirements through deployment and user adoption
• Experience mentoring or training interns, junior engineers, or technicians
• Lean Six Sigma Green Belt or Black Belt
• Experience with electronics/PCBA or high-volume electronics assembly
• Experience integrating tools with MES/ERP systems or manufacturing test data, and validating software used in production
• Ability to travel domestically and internationally to manufacturing partners