Sr Manufacturing Engineer - New Product Introduction (NPI)

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 highly regulated environment.
• Experience with new product introduction (1-3+ years) is highly desirable.
• Experience with statistical analysis of data (Ex. Minitab, JMP, etc.).

Benefits

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!

About the Role

Riverpoint Medical is committed to a diverse and inclusive workplace.

Schedule

N/A

Pay

N/A