Job Description
Description
CONTEXT
A growing medical device company specializing in steerable cardiac catheters is seeking an experienced Manufacturing Process Development & Scale‑Up Consultant. Reporting to the CTO (Head of R&D & Operations), the consultant will lead efforts to transition low-volume manufacturing to outsourced, scalable production, including site selection, knowledge transfer, pilot implementation, and full-scale launch. Ideal candidates bring big-company, multi-step catheter manufacturing expertise and a proven track record in outsourced medical device scale-up
Responsibilities
DUTIES/EXPECTATIONS OF THIS ROLE
Outsourced Manufacturer Selection & Onboarding
• Identify and evaluate potential US and global manufacturing partners capable of scaling catheter production
• Conduct site visits, due diligence, and comparative assessments for capacity, quality systems, and regulatory readiness
• Support contracting, MSA negotiation, and alignment of manufacturing scope
Knowledge Transfer & Pilot Program Design
• Lead knowledge transfer sessions, ensuring clear documentation of current catheter assembly processes
• Develop and manage pilot manufacturing protocols, including tolerances, throughput targets, and quality measures
• Set success metrics and advance-to-production criteria for pilot outcomes
Scale‑Up Planning & Execution
• Architect scalability roadmap: process flows, capacity planning, supply chain logistics, and automation potential
• Integrate quality systems, regulatory compliance, and process validation into scale-up transition
• Oversee supplier onboarding, staff training, and site readiness for production ramp
Continuous Improvement & Operations Enablement
• Implement statistical process control (SPC), lean manufacturing practices, and quality analytics
• Monitor operational KPIs during pilot and early production phases → adjust protocols for improvement
• Enable cross-functional collaboration: Manufacturing, Quality, Supply Chain, R&D, and external partners
Experience Requirements
MUST HAVES – QUALIFICATION SUMMARY
• 10+ years in manufacturing process development, scale-up, and transfer in regulated medical device environments, preferably in catheters or steerable cardiovascular devices
• Proven success managing outsourced manufacturing startups, from pilot through annual production volume (~10k units/year)
• Strong familiarity with multi-step catheter assembly processes: extrusion, braiding, bonding, coating, final assembly
• Experience conducting site qualification and knowledge transfers, driving pilot implementation and scale
• Demonstrated ability to operate with objectivity and autonomy, ideal for high-ambiguity, scaling environments
• Background at a large med-tech or medical device OEM
• Expertise in lean manufacturing, SPC, ISO 13485, FDA/CE regulatory landscapes
• Advanced degree in Engineering, Manufacturing, or related discipline
CONTEXT
A growing medical device company specializing in steerable cardiac catheters is seeking an experienced Manufacturing Process Development & Scale‑Up Consultant. Reporting to the CTO (Head of R&D & Operations), the consultant will lead efforts to transition low-volume manufacturing to outsourced, scalable production, including site selection, knowledge transfer, pilot implementation, and full-scale launch. Ideal candidates bring big-company, multi-step catheter manufacturing expertise and a proven track record in outsourced medical device scale-up
Responsibilities
DUTIES/EXPECTATIONS OF THIS ROLE
Outsourced Manufacturer Selection & Onboarding
• Identify and evaluate potential US and global manufacturing partners capable of scaling catheter production
• Conduct site visits, due diligence, and comparative assessments for capacity, quality systems, and regulatory readiness
• Support contracting, MSA negotiation, and alignment of manufacturing scope
Knowledge Transfer & Pilot Program Design
• Lead knowledge transfer sessions, ensuring clear documentation of current catheter assembly processes
• Develop and manage pilot manufacturing protocols, including tolerances, throughput targets, and quality measures
• Set success metrics and advance-to-production criteria for pilot outcomes
Scale‑Up Planning & Execution
• Architect scalability roadmap: process flows, capacity planning, supply chain logistics, and automation potential
• Integrate quality systems, regulatory compliance, and process validation into scale-up transition
• Oversee supplier onboarding, staff training, and site readiness for production ramp
Continuous Improvement & Operations Enablement
• Implement statistical process control (SPC), lean manufacturing practices, and quality analytics
• Monitor operational KPIs during pilot and early production phases → adjust protocols for improvement
• Enable cross-functional collaboration: Manufacturing, Quality, Supply Chain, R&D, and external partners
Experience Requirements
MUST HAVES – QUALIFICATION SUMMARY
• 10+ years in manufacturing process development, scale-up, and transfer in regulated medical device environments, preferably in catheters or steerable cardiovascular devices
• Proven success managing outsourced manufacturing startups, from pilot through annual production volume (~10k units/year)
• Strong familiarity with multi-step catheter assembly processes: extrusion, braiding, bonding, coating, final assembly
• Experience conducting site qualification and knowledge transfers, driving pilot implementation and scale
• Demonstrated ability to operate with objectivity and autonomy, ideal for high-ambiguity, scaling environments
• Background at a large med-tech or medical device OEM
• Expertise in lean manufacturing, SPC, ISO 13485, FDA/CE regulatory landscapes
• Advanced degree in Engineering, Manufacturing, or related discipline
💡 Quick Summary
Seeking a career-building opportunity? The Process Development Consultant position is now open for candidates interested in the Operations Executive Jobs sector. This role in Chicago offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Operations Executive Jobs is a plus.
