Sr Manufacturing Engineer - New Product Introduction (NPI)

RIVERPOINT MEDICAL LLC•Portland, OR

About The Position

As the Sr. Manufacturing Engineer on the New Product Introduction (NPI) team at Riverpoint Medical, you will be at the forefront of bringing innovative medical, dental, and veterinary devices from concept to full-scale production. Your primary mission will be to lead the successful transfer of new products and processes into manufacturing, ensuring robust, efficient, and compliant operations that support our growth and quality objectives.

Requirements

Bachelor’s or Master’s degree in Engineering (Manufacturing, Mechanical, Chemical, or Industrial preferred).
7-10 years’ experience in process or manufacturing engineering, with a strong track record in NPI and process transfer within a regulated manufacturing environment.
Demonstrated expertise in process validation, Lean/Six Sigma, and project management.
Experience leading cross-functional teams through product launches and process scale-up.
Strong analytical, problem-solving, and communication skills.
Experience in Medical Device (5+ years) or highly regulated environment
Experience with statistical analysis of data (Ex. Minitab, JMP, etc.)

Nice To Haves

Experience with new product introduction (1-3+ years) is highly desirable

Responsibilities

Lead end-to-end manufacturing process development and production transfer for new products.
Drive DFM/DFA strategy and provide early manufacturing input during design and development.
Own NPI manufacturing deliverables including process flows, work instructions, tooling, and equipment.
Create and define new manufacturing processes and assembly methods for complex or novel products.
Develop and author technically rigorous production work instructions, process documentation, and visual aids that translate design intent into repeatable, compliant manufacturing execution.
Define and lead operator training strategy for new products, including development of training materials, hands‑on training support, and verification of operator readiness during pilot builds and production ramp.
Plan and execute process validations (IQ/OQ/PQ) in compliance with FDA, ISO 13485, and internal quality systems.
Act as a manufacturing subject matter expert for NPI programs and influence cross-functional decisions.
Mentor other Manufacturing Engineer team members.
Balance quality, cost, delivery, and risk in manufacturing decisions.
Align technical solutions with overall business strategy and priorities.