Job description

Sr. Manufacturing Engineer Requirements :

2+ years of thermoplastic extrusion experience preferred.

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
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)
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 manual.
Ability to multi task on different projects and roles.
Function successfully in a high paced results-oriented environment

Sr. Manufacturing Responsibilities:

Must be able to develop and implement manufacturing related cost saving initiatives (Value
Improvement Projects).
Provide engineering support for the development and manufacturing of new products.
Evaluate proposed designs for manufacturability
Provide technical knowledge and manufacturing support for polymer extrusion processes.
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 extrusion 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
Lead functional and cross-functional teams to achieve project goals.
Mentor junior manufacturing engineers in project management activities