Senior NPI Engineer

Real Staffing; Santa Clarita (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Real Staffing Group is seeking a hands-on Senior Engineer, NPI in Santa Clarita to support new product introduction and manufacturing engineering activities. You will collaborate with R&D, Quality, Operations, Supply Chain, and Manufacturing to translate design requirements into robust, validated processes for regulated manufacturing.

The role emphasizes leading engineering activities on the shop floor, driving process improvements, and delivering measurable operational results in a highly

Qualifications

• Bachelor's degree in mechanical, manufacturing, or biomedical engineering.
• 5+ years in Manufacturing Engineering, NPI, or design transfer.
• Experience with IQ/OQ/PQ, DOE, statistics, PFMEA, risk mgmt.
• Strong documentation and validation protocol writing skills.
• Experience with laser welding, resistance welding, soldering, or EM manufacturing is a plus.
• Experience in regulated environments (medical device/automotive) preferred.
• Ability to lead engineering activities and drive improvements.

Responsibilities

• Lead manufacturing engineering and design transfer activities from product development through commercial manufacturing release.
• Develop manufacturing processes, specs, work instructions, inspection methods, acceptance criteria, and process controls for new products.
• Lead process characterization and validation activities, including IQ, OQ, and PQ, using DOE and statistics.
• Develop validation protocols, reports, and documentation for manufacturing readiness.
• Apply PFMEA and risk analysis to identify and mitigate process risks.
• Partner with R&D and cross-functional teams on manufacturability, DFM/DFA, traceability.
• Independently troubleshoot and drive improvements delivering measurable results.

Skills

Manufacturing engineering

Process validation

DOE

Statistical analysis

PFMEA

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Job description

Senior Engineer, NPI

We are looking for an experienced, hands-on Senior Engineer, NPI to support new product introduction and manufacturing engineering activities in Santa Clarita. In this role, you will work closely with R&D, Quality, Operations, Supply Chain, and Manufacturing to translate design requirements into robust, validated manufacturing processes. This is an ideal opportunity for an experienced engineer who enjoys working directly with manufacturing-floor processes, solving complex technical challenges, and independently driving projects in a highly regulated environment.

Responsibilities:

• Lead manufacturing engineering and design transfer activities from product development through commercial manufacturing release.
• Develop manufacturing processes, specifications, work instructions, inspection methods, acceptance criteria, and process controls for new product introductions.
• Lead process characterization and validation activities, including IQ, OQ, and PQ, utilizing statistical methods and Design of Experiments (DOE).
• Develop and write validation protocols, reports, and technical documentation required to support manufacturing readiness.
• Apply PFMEA and manufacturing risk analysis to identify, evaluate, and mitigate process risks.
• Partner with R&D and cross-functional teams to evaluate manufacturability, Design for Manufacturability (DFM), Design for Assembly (DFA), and traceability from design requirements through validated production processes.
• Independently troubleshoot complex manufacturing challenges and drive process improvements that deliver measurable operational and business results.

More about you:

• Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of experience in Manufacturing Engineering, NPI, Process Engineering, design transfer, or a related field.
• Strong experience with process validation, including IQ/OQ/PQ, DOE, statistical analysis, PFMEA, and manufacturing risk management.
• Strong technical and documentation writing skills, including experience developing validation protocols and reports.
• Experience working with manufacturing and assembly processes. Experience with laser welding, resistance welding, soldering, or electromechanical manufacturing is a plus.
• Experience in medical device, automotive, or another highly regulated manufacturing environment is strongly preferred.
• Demonstrated ability to independently lead manufacturing engineering activities, solve complex process challenges, and translate technical improvements into measurable operational or business results.

This is a on-site position. If you're interested in that role, feel free to reach out to me directly:

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com