Process Development Consultant

at Eliassen Group in

Augusta, Maine, United States Job Description 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 ( noreply@eliassen.com , 781-808-2924) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process. 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 .

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! To view full details and how to apply, please login or create a Job Seeker account