NPI Engineer

Lso Inc; Brea (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in the medical device sector is seeking an experienced NPI Engineer to join their Brea, CA office. This role is crucial for overseeing new product introduction activities, including project coordination, compliance, and cross-functional collaboration. Candidates should have a strong engineering background, particularly in the medical device industry, and exhibit excellent communication and organizational skills.

Qualifications

• 5–8 years of experience in a manufacturing environment, preferably in medical devices.
• Strong understanding of FDA and ISO 13485 standards.
• Familiarity with risk management and validation protocols.

Responsibilities

• Coordinate operational aspects of new projects for alignment with timelines.
• Develop and review Manufacturing Procedures and Work Instructions.
• Engage with customers in product development discussions.

Skills

Root cause investigation

Document control processes

Cleanroom operations

Strong communication

Organization skills

Education

Bachelor's Degree in Engineering

Tools

SolidWorks

eQMS system

Job description

Job Details

Level: Experienced

Job Location: Corporate Office LSO West - Brea, CA

Salary Range: $80000.00 - $120000.00

Company Description

(www.lso-inc.com) is in North Orange County in the city of Brea, California. Life Science Outsourcing, Inc (LSO) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions. Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping.

We are currently seeking a self-motivatedNPI Engineerwith positive, engagement and collaborative energy to join our team and support the continued growth of LSO. TheNPI Engineer is responsible for the execution and support of new product introduction (NPI) activities, process validation, and cross-functional coordination to ensure smooth transfer of products into manufacturing. This role supports development efforts from design concept through commercialization, ensuring compliance with regulatory standards and company objectives.

We encourage you to submit a resume with salary requirements.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES include the following. Other duties may be assigned.

Operational & Technical Responsibilities

• Coordinate day-to-day operational aspects of new projects to ensure alignment with project timelines.
• Execute validation builds (blue/pink work orders), and prepare samples for CDS, SVS, and MPT activities.
• Develop and review Manufacturing Procedures (MPs), Work Instructions (WIs), Routers, and Bills of Materials (BOMs).
• Prepare and maintain manufacturing documentation including protocols for Operational Qualification (OQ) and Performance Qualification (PQ).
• Participate in continuous improvement efforts targeting efficiency, quality, and cost reduction in new product manufacturing processes.
• Collaborate in the setup and optimization of sealing processes and other production activities for new products.
• Contribute to the creation of standardized work instructions and process documentation for new product lines.
• Support execution of time studies and other operational readiness assessments during prospect reviews.

Customer Collaboration & Cross-Functional Engagement

• Engage directly with customers in product development discussions to align design and process expectations.
• Investigate customer complaints by participating in root cause analyses and corrective action planning.
• Collaborate with documentation teams to monitor and complete change orders efficiently using the eQMS system.
• Interact with labels, quality control, planning, and manufacturing to support both ongoing and new product requirements.
• Assist Program Managers and NPI teams by providing technical insight and support for engineering-driven activities.

QUALIFICATIONS -To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s Degree in Engineering or a related technical discipline (required).
• 5–8 years of experience in a manufacturing environment, preferably within the medical device industry.
• Strong understanding of cleanroom operations and documentation in regulated environments (e.g., FDA, ISO 13485).
• Familiarity with risk management practices, validation protocols, and electronic Quality Management Systems (eQMS).
• Skilled in root cause investigation, CAPA support, and document control processes.
• Proficient in using SolidWorks or similar CAD tools is a plus.
• Strong communication, organization, and documentation skills.
• Ability to work independently while collaborating effectively across teams.