Life Science Outsourcing, Inc. 

(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.

In January of 2021 LSO has partnered with PPC Enterprises (www.ppcenterprises.com), a leading private equity firm based out of New York to expand LSO’s geographic reach in the medical device arena. Due to the recent acquisition and 24 years of growth, we are currently seeking a self-motivated Manufacturing Engineer with a good positive energy to join our team. In this role you will be responsible for Providing technical and sustaining engineering support in a manufacturing area. The Manufacturing Engineer plays a significant and strategic role in the success of LSO and reports directly to the Director of Manufacturing.

We encourage you to submit a resume with salary requirements

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

• Execute remediation validation/ verification activities such as: Installation Qualification (IQ), Operations Qualification (OQ), Process Qualification (PQ)/Process Performance Qualification (PPQ), Test Method Validations (TMVs), Process Characterization.
• Provides technical and sustaining engineering support in a manufacturing and production assembly area.
• Recommends and implements tooling, equipment, and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products
• Provides New Product Introduction (NPI) Support across multiple production assembly lines supporting a wide variety of devices.
• May develop and conduct statistical analysis or recommend additions to document work.
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
• Experienced in LEAN Manufacturing methods and Techniques such as 5S.
• Ensures processes and procedures are in compliance with regulations.
• Assess data, write protocols / reports, execute changes.
• Develops work instructions and routers in support of production assembly.
• Recommending changes and training operators for the change and overseeing the execution of engineering work orders.

SKILLS

• Hands on experience working in a regulated production environment - Medical Device, Aerospace, Automotive
• Process Verification and Validation
• IQ, OQ, PQ
• Assembly and Test Method Validations
• Assess data, write protocols / reports, execute changes
• Recommending changes and training operators for the change and overseeing the execution of engineering work orders
• Assembly tooling design and implementation experience in both low and high-volume production environments
• Implementing equipment and process modifications
• Good verbal and written communication skills
• Basic knowledge of and competency with mechanical design tools – Solidworks or equivalent

EXPERIENCE:

• Requires a university 4 -Year Degree and minimum of 5+ years of relevant experience. 
• Experience supporting production assembly in a regulated environment
• Lean Manufacturing Training
• Project Management experience is a plus.