Job Details

About Us:

Poly-Med is the leading developer of bioresorbable polymers and fibers. We help innovative medical device companies focused on improving patient outcomes. Poly-Med designs, develops and manufactures superior materials to get customer products to market in the most efficient manner with the greatest improvement to quality of life. Located in Anderson, South Carolina, Poly-Med, Inc. has been recognized as a leader in the industry for over 20 years. Poly-Med continues to grow in a multitude of medical device modalities. Our novel materials are key in actively enabling products ranging from vascular stents, hernia meshes, dental delivery systems, dental hygiene, and a variety of wound closure applications in the worldwide medical device market.

For additional information, visit our website at www.Poly-Med.com.

Our Team:

We employ a widely diverse team comprised of experts from material science, chemical engineering, mechanical engineering, bioengineering, biology, business marketing, and project management to create a work environment focused on solving tough medically related problems. Our team is energetic, resourceful, and, above all, collaborative. We are searching for like-minded talent to build on our success and continue our quest to improve patient outcomes through novel polymeric and drug delivery systems.

Description for the Senior Extrusion Engineer:

This position will aid in the implementation of product design and process development activities for extruded products with compliance to all quality and regulatory requirements. This is a full-time, on-site position. This role is an Independent Contributor role. There are no direct reports for this position. Interaction is potentially with all levels of the organization.

Assist in interfacing with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.

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Responsibilities for the Senior Extrusion Engineer

Position Duties (must relate to the position purpose/role):

• Direct activities around the design and development of new products and fabricate prototypes in conjunction with appropriate staff
• Develop and execute process validations and design verification testing.
• Develop test methods including test method validation using statistical methods.
• Direct technical effort in developing specifications for a product and/or process.
• Give technical input when implementing corrective actions (CAPA) with QA where applicable.
• Direct equipment IQ/OQ/PQ validations.
• Direct OQ/PQ process validations.
• Lead FMEA on new processes and give technical guidance on existing FMEAs.
• Give technical guidance on manufacturing deviations.
• Provide mentorship to less experienced engineers.
• Conceptualize new product ideas and related feasibility trials.
• Work independently with a project manager, or act as a project manager for small technical projects, to follow a scope and budget to deliver projects in a timely manner.
• Direct technical efforts in development project teams.
• Utilize existing literature and experimental data to create novel ideas.
• Recommend and pursue process improvement ideas.
• Write and review technical reports detailing procedures, outcomes, and observations.
• Support projects at the work location that requires the assigned effort or task completion.
• Perform other duties as assigned.

Required/Preferable Knowledge, Skills and Abilities for Extrusion Engineer:

• Advanced degree preferred or relevant years of experience.
• Requires expertise in respective area of focus.
• Experience working under a highly regulated quality management system.
• Ability to communicate written and orally with clear objectives, results, conclusions, and recommendations.
• Ability to understand project or process risks and communicate to project managers.
• Potential to be SME/technical lead on an internal project within respective area of focus with a project manager.
• Working knowledge of specification development where applicable. · Ability to mentor engineers in respective area of focus.
• Working knowledge of design control procedures where applicable. · Resorbable materials experience (processing).
• Experience working with automation design and implementation. · Experience working with materials packaging.
• Experience with scale of processes.
• Melt processing and/or Injection Molding Experience. Ability to interface with external vendors and contractors specifically when dealing with processes running offsite.

Education/Experience Requirements for Extrusion Engineer:

Bachelor's Degree in applicable field of science or engineering with approximately >5 years of related experience or Bachelor's Degree in applicable field of science.

Working Conditions at Poly-Med, Inc.:

At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.

Physical Requirements:

Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

• Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.