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SR Manufacturing Engineer in East Texas, PA at HumCap Recruiting

Date Posted: 12/6/2018

Job Snapshot

Job Description

Description:SR
Manufacturing Engineer

SUMMARY

This position will drive manufacturing
engineering projects, including the design and development of processes,
equipment, and documentation to successfully implement new products into
manufacturing.  Enhance productivity and
product quality of existing products and processes with a strong emphasis on
Lean to ensure quality and manufacturability by enforcing engineering and
manufacturing guidelines.  Effectively
manage and communicate progress toward project goals to management. 

ESSENTIAL
DUTIES AND RESPONSIBILITIES

Provide
engineering support for the development and manufacture of Medical products.
Evaluate proposed designs for manufacturability



Provide
technical expertise for manufacturing support of polymer extrusion processes.
Recommend,
develop and implement manufacturing related cost saving initiatives (Value
Improvement Projects).
Develop
and implement process validation protocols and reports.
Perform root cause analysis of product/process
issues and implement short and long-term corrective actions to improve product
quality and reliability. 
Analyze
and plan work force utilization, space requirements, and workflow and designs
layout of equipment and workspace for maximum efficiency.
Confer
with planning and design staff concerning product design and tooling to ensure
efficient production methods.
Confer
with vendors to determine product specifications and arrange for purchase of
equipment, materials or parts and evaluate products according to specifications
and quality standards.
Estimate
production times, staffing requirements, and related costs to provide
information for management decisions.
Confer
with management, engineering, and other staff regarding production
capabilities, production schedules, and other considerations to facilitate
production processes.
Apply
statistical methods to estimate future production requirements and potential.
Execute
problem solving, efficiency studies, and the identification of process
improvement opportunities.
Provide
assistance in troubleshooting manufacturing and packaging areas.
Work
in conjunction with Maintenance Department to identify, recommend and implement
the upgrade and automation of current equipment and the purchase of new
equipment within regulatory requirements.
Develop, implement, train and monitor
effectiveness of engineering systems and procedures to ensure compliance to
FDA, cGMP and all other applicable agency regulations









LEADERSHIP RESPONSIBILITIES

Lead
functional and cross-functional teams to achieve project goals
Mentor
junior manufacturing engineers in project management activities
EDUCATION
AND/OR EXPERIENCE

Bachelor’s
Degree or higher, in polymer engineering, material science, mechanical or
industrial engineering
Minimum
of five (5) years related experience in and FDA/GMP regulated industry
2+
years of thermoplastic extrusion experience preferred.
Proficient in AutoCAD,
SolidWorks, Minitab, Word, Excel and Project
Experience
in product production planning and working knowledge of manufacturing methods,
procedures and cost reduction/yield improvement techniques
Background
in medical device assembly, automation, and vision system technology
Experience
in the application of statistical techniques such as statistical process
control, design of experiments, and problem-solving techniques is required
Experience
with design, review, execution, and approval of Installation, Operation and
Process Qualification protocols and reports (IQ/OQ/PQ)
QUALIFICATIONS
Excellent
verbal and communication skills
Proven
record of delivering multi-disciplinary projects on time and on budget
Ability
to apply mathematical operations to such tasks as frequency distribution,
determination of test reliability and validity, analysis of variance,
correlation techniques, sampling theory and factor analysis
Define
problems, collect data, establish facts, and draw valid conclusions
Interpret
an extensive variety of technical instructions in mathematical or diagram form
and deal with several abstract and concrete variables
Read,
analyze and interpret general business periodicals, professional journals,
technical procedures, or governmental regulations
Write
reports, business correspondence and procedure manuals
Ability
to drive change
Ability
to lead cross-functional/department teams
Ability
to prioritize for maximum results (multi-task management)
Effective
multi-channel communicator
Function
successfully in a high paced results-oriented environment
Function
well within a team environment