
location_on534, Landis Road, Lederach, Harleysville, Lower Salford Township, Montgomery County, Pennsylvania, 19438, United States
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.
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.
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.
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 model: On-site
534, Landis Road, Lederach, Harleysville, Lower Salford Township, Montgomery County, Pennsylvania, 19438, United States
Lower Salford Township, Pennsylvania
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.
Knowledge of ISO 10993. Experience with SolidWorks. Lean Manufacturing certification (Green Belt).
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