Material Science Engineer - Biocompatibility ISO 10993

Material Science Engineer Location:

• Preference will be given to candidates located within a reasonable commuting distance of Harleysville, PA for on-site work. Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA, NJ, NC, TN, or TX.

Please note:

• This position is not eligible for relocation assistance or employment sponsorship now or in the future.
• Position Summary We are seeking a Materials Engineer to provide technical expertise in material selection and qualification for the design and development of disposable medical devices—from concept through commercialization.
• This role collaborates closely with cross-functional engineering teams and ensures adherence to Design Control standards, quality systems, and regulatory requirements.
• The ideal candidate will bring strong experience in material characterization, material science, medical device manufacturing, ISO 10993, EU MDR, FDA Guidance regulatory compliance and leadership/mentorship within engineering teams.
• Key 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%).
• Required Qualifications Education & Experience 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 Technical Skills Knowledge of ISO 10993, ISO 14971 is required.
• Familiarity with FDA, GMP, GLP, and EU MDR regulations.
• Experience with CAD software (SolidWorks preferred).
• 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.
• Additional Skills 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).
• Core Competencies Problem solving and analytical thinking.
• Technical expertise and continuous learning mindset.
• Collaboration and teamwork.
• Communication (written and verbal).
• Quality focus and attention to detail.
• Leadership and mentoring.
• Adaptability and initiative.
• Sound judgment and decision-making.
• Physical Requirements 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.
• Work Environment Combination of office, manufacturing floor, engineering lab, and prototype shop environments.
• Exposure to mechanical equipment and moderate noise levels.

Additional Information Travel required:

• 5–15%.
• Must have or be able to obtain a valid passport.
• Equal Opportunity Statement 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.
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