Process Development Consultant

About the Role

Title: Process Development Consultant

Anywhere

Type: Contract
Category: Manufacturing
Industry: Life Sciences
Workplace Type: Remote
Reference ID: JN -042026-106275

Job 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

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.