Material Science Engineer - Biocompatibility ISO 10993

Summary

Medical Components, Inc. is seeking a Materials Engineer to provide technical expertise in material selection and qualification for disposable medical devices from concept through commercialization. The role collaborates with cross-functional engineering, biocompatibility, manufacturing, and regulatory teams while ensuring compliance with design control, quality systems, ISO 10993, EU MDR, and FDA requirements.

Responsibilities

• Lead material selection and qualification processes for product design and development
• Evaluate material changes and define/execute required validation and testing
• Review product designs for material manufacturability, performance, and cost efficiency
• Ensure proper review and release of materials, drawings, and documentation
• Assess material properties and compatibility for intended product use
• Collaborate with suppliers to define material processing and support production needs
• Collaborate with Biocompatibility, Manufacturing, Research & Development (R&D), and New Product Development (NPD) teams to support material science, chemical characterization, and product safety activities for FDA, EU MDR, and global regulatory submissions, technical documentation, and regulatory responses
• Evaluate material composition, additives, impurities, processing aids, degradation products, and residual chemicals
• Assess material, supplier, formulation, manufacturing, sterilization, and packaging changes, determine requires testing, validation, risk assessment, and regulatory documentation for proposed changes
• Prepare responses to FDA, notified body, and other regulatory deficiencies related to materials and biocompatibility
• Interpret and review complex chemical data sets from outside analytical and biological laboratories and compare results to supplier documentation
• Evaluate scientific evidence and develop defensible conclusions using a weight-of-evidence approach
• Maintain material and material property databases
• Support manufacturing operations and resolve production issues
• Travel to other facilities as needed (5–15%)

Skills

• Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA, NJ, NC, TN, or TX
• This position is not eligible for relocation assistance or employment sponsorship now or in the future
• Bachelor's degree in Materials Science, Polymer Science, Chemistry or related technical field
• 3–5 years of experience in manufacturing or medical device industry
• Strong experience in material characterization and selection in accordance with ISO 14971, ISO 10993 Series of Standards, EU MDR, and FDA Guidance
• Experience in engineering design, validation, and product testing environments
• Knowledge of ISO 10993, ISO 14971 is required
• Familiarity with FDA, GMP, GLP, and EU MDR regulations
• Knowledge of injection molding, extrusion, and secondary operations
• Understanding of GD&T and engineering drawings
• Experience with validation testing methods and statistical analysis
• Familiarity with FEA and mold flow analysis
• Strong problem-solving and analytical abilities
• Excellent written and verbal communication skills
• Ability to lead projects and mentor team members
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook)
• Ability to sit, stand, walk, and use hands regularly
• Occasional lifting up to 25 lbs
• Ability to work in manufacturing, lab, and prototype environments
• Vision abilities including close and distance vision, color vision, and depth perception
• Travel required: 5–15%
• Must have or be able to obtain a valid passport
• Preference will be given to candidates located within a reasonable commuting distance of Harleysville, PA for on-site work
• Experience with CAD software (SolidWorks preferred)

Qualifications

Must Haves

• Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA, NJ, NC, TN, or TX
• This position is not eligible for relocation assistance or employment sponsorship now or in the future
• Bachelor's degree in Materials Science, Polymer Science, Chemistry or related technical field
• 3–5 years of experience in manufacturing or medical device industry
• Strong experience in material characterization and selection in accordance with ISO 14971, ISO 10993 Series of Standards, EU MDR, and FDA Guidance
• Experience in engineering design, validation, and product testing environments
• Knowledge of ISO 10993, ISO 14971 is required
• Familiarity with FDA, GMP, GLP, and EU MDR regulations
• Knowledge of injection molding, extrusion, and secondary operations
• Understanding of GD&T and engineering drawings
• Experience with validation testing methods and statistical analysis
• Familiarity with FEA and mold flow analysis
• Strong problem-solving and analytical abilities
• Excellent written and verbal communication skills
• Ability to lead projects and mentor team members
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook)
• Ability to sit, stand, walk, and use hands regularly
• Occasional lifting up to 25 lbs
• Ability to work in manufacturing, lab, and prototype environments
• Vision abilities including close and distance vision, color vision, and depth perception
• Travel required: 5–15%
• Must have or be able to obtain a valid passport

Nice to Haves

• Preference will be given to candidates located within a reasonable commuting distance of Harleysville, PA for on-site work
• Experience with CAD software (SolidWorks preferred)

Benefits

• Remote work may be considered for exceptionally qualified candidates residing in AZ, FL, GA, NJ, NC, TN, or TX.