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Process Development Consultant
- Albany, New York, United States
- Albany, New York, United States
À propos
Type:
Contract
Category:
Manufacturing
Industry:
Life Sciences
Workplace Type:
Remote
Reference ID:
JN-042026-106275
Date Posted:
04/05/2026
Description 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
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 and adjust protocols for improvement
Enable cross‑functional collaboration: Manufacturing, Quality, Supply Chain, R&D, and external partners
Experience Requirements
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
Benefits 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.
Other employment options may be available that may result in pay outside of the provided range.
EEO Statement Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Aff... [text truncated for brevity] ... and protected by federal, state, or local laws.
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Compétences linguistiques
- English
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