Process Development Consultant

• Process Development Consultant
• Anywhere

• Type:

• Contract

• Category:

• Manufacturing

• Industry:

• Life Sciences

• Workplace Type:

• Remote

• Reference ID:

• JN -042026-106275

• Date Posted:

• 04/05/2026

• Shortcut:

• http://careers.eliassen.com/ItgWZe + Description + Recommended Jobs

• 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
• _Recruitment Transparency Notice_
• _Eliassen 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_
• _and hiring_
• _process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_
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• _, 781-808-2924) inviting you to complete a brief voice screening as part of your application process.

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• _Skills, experience, and other compensable factors will be considered when determining pay rate.

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About Eliassen Group:

_ _Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve._ _Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws._ _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!_