Job Title: Manufacturing Engineer
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
- 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..
- 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.
- Other duties may be assigned
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.
- Hands on experience working in a regulated production environment - Medical Device, Aerospace,
- 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
- Requires a university 4 -Year Degree Mechanical Engineering- Preferred
- Minimum of 4-5+ years of relevant experience.
- Background in project work bringing new products from prototype thru pilot production
- Experience supporting production assembly in a regulated environment
* 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.