Senior Project Engineer
Company: Austin Vita
Location: Brea
Posted on: August 8, 2022
Job Description:
BASIC FUNCTIONS
- Provides technical Process Engineering support associated with
NPI and Product Transfer to Production
- Assist to produce Quality Products on time and within
budget.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES include the
following:
- 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 process engineering support in a
manufacturing and production assembly environment.
- Recommends and implements tooling, equipment, and process
modifications to meet quality standards and improve production
efficiencies, manufacturing techniques as well as production yields
for new projects
- 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 per program/project.
- Develops manufacturing processes that are applicable to
statistical process control and may develop those techniques
including the measurement systems.
- Execute 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 new
project production assembly.
- Recommending changes and support training project lead and
manufacturing technicians, while for the overseeing the execution
of engineering work orders.
- Other duties may be assignedQUALIFICATIONS 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.
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 equivalentEXPERIENCE:
- Requires a university 4 -Year Degree Mechanical Engineering-
Preferred
- Minimum of 7+ years of relevant experience.
- Background in project work bringing new products from prototype
thru pilot production
- Experience in Leading a project team to execute NPI
process
- Experience in communicating the "Big Picture" of NPI
manufacturing needs and ensure alignment with assembly and
management team at all steps in the process.
- Experience supporting production assembly in a regulated
environment
- Lean Manufacturing Training
- Project Management experience is a plus.PHYSICAL DEMANDS
- Must be physically able to sit or stand for extended periods of
time.
- Must have the ability to walk up and down stairs repeatedly and
walk extended distances as needed.
Keywords: Austin Vita, Fullerton , Senior Project Engineer, Engineering , Brea, California
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