Sr Manufacturing Engineer - New Product Introduction (NPI) at RIVERPOINT MEDICAL LLC

Portland, Oregon, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

0.0

Posted On

13 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Production Transfer, DFM/DFA, Work Instructions, Tooling, Equipment Definition, Process Validation, IQ/OQ/PQ, FDA Compliance, ISO 13485, Cross-functional Leadership, Process Scale-up, Analytical Skills, Problem-Solving, Communication Skills, Statistical Analysis

Industry

Medical Equipment Manufacturing

Description

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. Duties and Responsibilities for the position include: * 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. Education and Qualifications * 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 new product introduction (1-3+ years) is highly desirable * Experience with statistical analysis of data (Ex. Minitab, JMP, etc.) We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus! https://rpmed.com/pages/careers Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status

Responsibilities

The primary mission is to lead the successful transfer of new medical, dental, and veterinary devices from concept to full-scale production, ensuring robust, efficient, and compliant manufacturing operations. This involves leading end-to-end manufacturing process development, owning NPI manufacturing deliverables, and defining new processes for complex products.