NPI Process Engineer

Position/Title: NPI Process Engineer

Department: R&D

Supervisor: VP of R&D

FLSA Status: Exempt

About the Company: Valencia Technologies is a neuromodulation company transforming the standard of care for urgency urinary incontinence with the development of our revolutionary eCoin technology. Valencia Technologies is ramping up all aspects of business to deliver effective therapy and impact the lives of millions. Join our mission to become the market leader in overactive bladder care as we bring patients and physicians a better therapy now and beyond, put patients first, and be a place of respect, excellence, and honesty for our employees and clients.

Job Summary: eCoin is a neurostimulator that is targeted towards treating urge urinary incontinence and has been commercially available since 2022. Valencia Technologies is looking for an NPI Process Engineer to accelerate the development of the next-generation eCoin. In this role, the person will be part of the R&D team, with responsibilities towards design verification and validation, process development for new products, and performing process validations, including tools and fixtures associated with manufacturing. The person should be self-motivated, able to take ownership to develop the documentation, cross-functionally work with the team and stakeholders to get alignment, and work under schedules to implement the solutions. Prior experience with manufacturing process development for medical devices is a must for this role.

Responsibilities/Tasks: As the NPI Process Engineer, you will be responsible for:

• Ability to take tooling drawings, draft process plans, and concept build ideas to convert to formal Assembly Procedures
• Develop necessary Work Instructions, Test Procedures, Travelers, Process Aids to aid with the process
• Manage builds for new product introduction in prototype and pilot production settings, including operator training and coordination with production planning.
• Partner with manufacturing and quality counterparts to get buy-in into the process
• Apply DFM principles to tooling & processes
• Aid R&D team with Design Verification testing and reports
• Perform Process Validations for newly developed processes for product launch
• Perform Packaging Validations for new product launch
• Contribute towards developing Receiving Inspection, First Article Inspection, Automated Test Equipment (ATE) setup
• Help with ATE troubleshooting and sustaining the process
• Contribute to developing pFMEAs with the Manufacturing Engineering team.

Qualifications:

• Bachelor's degree in a major science discipline
• 3-5 years of experience in manufacturing to develop/ sustain process and tools
• Experience with medical devices, preferably implantable
• Ability to read drawings, BOMs to understand tolerance stack up and identify issues for assemblies
• SolidWorks CAD capabilities is a bonus
• Understanding of challenges associated with NPI
• Good understanding of design verification and process validation
• Familiar with IQ/OQ/PQ and able to draft documents independently
• Good understanding of statistical concepts, sample sizes, Design of Experiments (DOE)

Benefits:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• 401K with Employer Matching
• Paid Time Off
• Paid Holidays
• Professional Development Reimbursement
• Annual Bonus Eligibility

Valencia Technologies is proud to be an equal opportunity workplace and is an affirmative action employer