Process Development Consultant
Eliassen Group
- Augusta, Georgia, United States
- Augusta, Georgia, United States
À propos
Type: Contract
Category: Manufacturing
Industry: Life Sciences
Workplace Type: Remote
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, 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 SPC, lean manufacturing practices, quality analytics; monitor operational KPIs during pilot and early production phases and adjust protocols; enable cross‑functional collaboration among 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.
Compensation 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.
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.
Equal Employment Opportunity Statement 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.
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Compétences linguistiques
- English
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