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  1. Home
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  3. engineering
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  5. Materials Engineer
Medical Components, Inc. logo

Materials Engineer

Not Disclosed•Full-TimeOn-site

location_on534, Landis Road, Lederach, Harleysville, Lower Salford Township, Montgomery County, Pennsylvania, 19438, United States

Apply Now

About the Role

We are seeking a Materials Engineer to provide technical expertise in material selection and qualification for the design and development of disposable medical devices, spanning from concept through commercialization. This role is critical in ensuring that our products meet rigorous Design Control standards, quality systems, and regulatory requirements while collaborating closely with cross-functional engineering teams.

The ideal candidate will bring strong experience in material characterization, medical device manufacturing, and leadership within engineering teams. You will partner with R&D, Manufacturing, Quality, Regulatory, and Biocompatibility teams to evaluate material changes, define validation strategies, and drive corrective actions for product failures. This position offers the opportunity to mentor team members and lead projects that impact the manufacturability, performance, and cost efficiency of our medical solutions.

Work Environment & Location

This position is based in Harleysville, PA. Local candidates only are required, as on-site work is necessary on a weekly basis. The role involves a combination of office, manufacturing floor, engineering lab, and prototype shop environments, with exposure to mechanical equipment and moderate noise levels. Candidates must be within a reasonable commute distance; this position does not offer relocation assistance or sponsorship.

Hiring Process

Candidates selected for this role will be expected to travel to other facilities as needed (5–15%) and must have or be able to obtain a valid passport.

Equal Opportunity

We are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants regardless of race, color, religion, gender, age, disability, or veteran status.

Work location

Work model: On-site

location_on

534, Landis Road, Lederach, Harleysville, Lower Salford Township, Montgomery County, Pennsylvania, 19438, United States

Lower Salford Township, Pennsylvania

Key Responsibilities

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Skills, education and keywords

Skills: Iso Standards, Iso 10993, Fda, GMP, GLP, Eu MDR, Solidworks, Cad, Injection Molding, Extrusion.

Education: Bachelor's degree in Engineering, Materials Science, or related technical field required.

Frequently asked questions about Materials Engineer at Medical Components, Inc.

What does a Materials Engineer at Medical Components, Inc. do?expand_more
In this Materials Engineer at Medical Components, Inc. role, you will lead material selection and qualification processes for product design and development; evaluate material changes and define required validation and testing protocols; review product designs for manufacturability, performance, and cost efficiency; and develop and maintain specifications, bills of materials, routers, sops, and sups.
What are the requirements for this Materials Engineer role?expand_more
Medical Components, Inc. is looking for candidates who meet the following requirements: Bachelor's degree in Engineering, Materials Science, or related technical field; 3–5 years of experience in manufacturing or medical device industry; Knowledge of ISO standards (ISO 10993 preferred); Familiarity with FDA, GMP, GLP, and EU MDR regulations; Experience with CAD software (SolidWorks preferred); and Knowledge of injection molding, extrusion, and secondary operations.
Where is the Materials Engineer role at Medical Components, Inc. located?expand_more
Materials Engineer at Medical Components, Inc. is based in 534, Landis Road, Lederach, Harleysville, Lower Salford Township, Montgomery County, Pennsylvania, 19438, United States. This is a on-site role.
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check_circle
Lead material selection and qualification processes for product design and development
  • check_circleEvaluate material changes and define required validation and testing protocols
  • check_circleReview product designs for manufacturability, performance, and cost efficiency
  • check_circleDevelop and maintain specifications, bills of materials, routers, SOPs, and SUPs
  • check_circleCollaborate with cross-functional teams including R&D, Manufacturing, and Quality
  • check_circleConduct root cause analysis on product failures and drive corrective actions
  • check_circleWrite and execute product testing protocols per ASTM/ISO standards
  • check_circleSupport regulatory submissions and ensure global material compliance
  • check_circleMentor team members and provide leadership across engineering functions
  • check_circleAssist with feasibility studies and ROI analysis for capital projects
  • Requirements

    • verifiedBachelor's degree in Engineering, Materials Science, or related technical field
    • verified3–5 years of experience in manufacturing or medical device industry
    • verifiedKnowledge of ISO standards (ISO 10993 preferred)
    • verifiedFamiliarity with FDA, GMP, GLP, and EU MDR regulations
    • verifiedExperience with CAD software (SolidWorks preferred)
    • verifiedKnowledge of injection molding, extrusion, and secondary operations
    • verifiedUnderstanding of GD&T and engineering drawings
    • verifiedExperience with validation testing methods and statistical analysis
    • verifiedFamiliarity with FEA and mold flow analysis
    • verifiedProficiency in Microsoft Office
    • verifiedLean Manufacturing certification (Green Belt preferred)
    • verifiedMust have or be able to obtain a valid passport

    Nice to Have

    Knowledge of ISO 10993. Experience with SolidWorks. Lean Manufacturing certification (Green Belt).

    Medical Components, Inc. logo
    Company

    Medical Components, Inc.

    Industry

    engineering

    View company profilearrow_forwardlanguageWebsite
    Quick Overview

    Experience

    3-5 yrs (Mid Level)

    Education

    Bachelor's degree in Engineering, Materials Science, or related technical field required

    Job Type

    Full-Time

    Skills Required

    Iso StandardsIso 10993FdaGMPGLPEu MDR
    arrow_forward
    Is this Materials Engineer job remote, hybrid, or on-site?expand_more
    Medical Components, Inc. has listed this Materials Engineer role as on-site.
    How much experience is required for this Materials Engineer role?expand_more
    Materials Engineer at Medical Components, Inc. typically requires 3–5 years of relevant experience at the mid level level.
    What skills do you need for the Materials Engineer role at Medical Components, Inc.?expand_more
    Key skills for Materials Engineer at Medical Components, Inc. include Iso Standards; Iso 10993; Fda; GMP; GLP; Eu MDR; Solidworks; and Cad.
    What education is required for Materials Engineer at Medical Components, Inc.?expand_more
    Educational requirements for this role: Bachelor's degree in Engineering, Materials Science, or related technical field required.
    What category does the Materials Engineer role belong to?expand_more
    Materials Engineer at Medical Components, Inc. is part of the engineering job category on Recrutus.
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    Solidworks
    Cad
    Injection Molding
    Extrusion