Sr Manufacturing Engineer - New Product Introduction (NPI)

SupportFinity™; Portland (OR); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, and Vision insurance

401(k) with contribution

Paid Time Off

Job summary

SupportFinity™ is seeking a Sr Manufacturing Engineer for New Product Introduction. This position, located in Portland, OR, involves leading the transfer of new medical devices from concept to production while ensuring compliance and efficiency.

You'll need 7-10 years of experience in a regulated environment, strong skills in process validation and Lean/Six Sigma methodologies. Benefits include comprehensive insurance plans and a 401(k) with company matching.

Qualifications

• 7–10 years’ experience in process or manufacturing engineering.
• Demonstrated expertise in process validation, Lean/Six Sigma, and project management.
• Experience leading cross‑functional teams through product launches.

Responsibilities

• Lead end‑to‑end manufacturing process development for new products.
• Drive DFM/DFA strategy and provide early manufacturing input.
• Create new manufacturing processes and assembly methods.

Skills

Process validation

Lean/Six Sigma

Project management

Analytical skills

Problem-solving

Communication

Education

Bachelor’s or Master’s degree in Engineering

Tools

Minitab

JMP

Job description

Sr Manufacturing Engineer - New Product Introduction (NPI)

Riverpoint Medical – Full‑time – Portland, OR – Posted Mar 13, 2024.

Overview

As the Sr. Manufacturing Engineer on the New Product Introduction team, you will lead the transfer of new medical, dental, and veterinary devices from concept to full‑scale production, ensuring robust, efficient, and compliant operations that support our growth and quality objectives.

Duties and 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.

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 in a highly regulated environment.
• Experience with new product introduction (1–3+ years) is highly desirable.
• Experience with statistical analysis of data (e.g., Minitab, JMP, etc.).

Benefits

Medical, Dental, and Vision insurance; Life and Accidental Death & Dismemberment insurance; 401(k) with mandatory contribution and mandatory vesting; Paid Time Off and 9 company‑mandated holidays; Bonus programs including Referral and Annual Bonus.

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 any other legally protected status.