Sr Manufacturing Operations Project Specialist

Veranex, Inc.•Providence, RI

2d•Onsite

About The Position

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. About This Role This client-facing role combines engineering experience with project and operations knowledge to ensure successful delivery of Manufacturing service and production projects. The position executes manufacturing operations projects from transfer to completion, ensuring they are delivered on time, within budget, and to the highest quality standards. Responsibilities include managing project timelines, budgets, and resources, conducting risk assessments, and maintaining continuous communication between internal teams and clients. The role also contributes to proposal development, process optimization, and performance improvement initiatives to enhance efficiency and client satisfaction. Strong engineering knowledge, communication, and leadership skills are critical, as this position serves as the primary point of contact for clients while bridging technical and operational goals.

Requirements

Bachelor’s degree in engineering discipline (or equivalent combination of education, training, and experience).
Engineering background with strong technical and operational understanding of manufacturing and manufacturing transfer processes.
4 - 7 years of relevant work experience.
Strong organizational and analytical abilities.
Experience managing multiple engineering or production projects simultaneously.
Proficiency with operations software.
Leadership, problem-solving, and continuous improvement mindset.
Strong interpersonal skills and attention to detail.
Ability to multi-task and work under timelines.
Comfortable working in cross-functional teams.

Nice To Haves

Experience with ISO13485, FDA Requirements and cGMP as related to medical device contract manufacturers or similar regulated industries.
Exceptional client communication and relationship management skills.
Strong project management skills and understanding of related processes.
Experience in MedTech or regulated product development and manufacturing environments.
PMP Certification a plus.
Working knowledge of timeline (i.e. Gantt) management tools such as SmartSheet, Microsoft Project, Power Bi etc.

Responsibilities

Develop detailed project plans, budgets, proposals, and resource schedules aligned with technical and client requirements.
Act as the main client contact throughout the project lifecycle, providing updates, addressing technical inquiries, and ensuring client expectations are met or exceeded.
Apply engineering principles to assess feasibility, set performance standards, and ensure project deliverables meet technical specifications.
Analyze workflows and implement systems and process changes to improve efficiency, reduce waste, and optimize productivity across engineering and production operations. Help create and implement an Operations Transfer Plan.
Monitor and manage personnel, tools, and equipment to maintain balanced project resource allocation.
Facilitate information flow between engineering, production, and management teams to support cross-functional collaboration.
Identify and mitigate potential technical and operational risks to maintain safety, compliance, and delivery standards.
Oversee project milestones, manage schedules, and compile comprehensive production and progress reports.
Ensure all engineering and production deliverables meet required quality, technical, and compliance standards before client delivery.
Manufacturing SME leading and creating service proposals as needed to support customer requirements.