Process Development Consultant
Anywhere
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:
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.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
· Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact fraud@eliassen.com.
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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. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contactInfoSec@eliassen.com.
Please ensure that you are working directly with us by confirming the following:
- When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
- Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group, as indicated above