Description: CONTEXTA 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 ROLEOutsourced 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
Recruitment Transparency NoticeEliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact .About Eliassen Group:Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate.Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check! 
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