Note: The job is a remote job and is open to candidates in USA. Medical Components, Inc. is a medical device company developing disposable medical devices. The Materials Engineer will provide technical expertise in material selection, characterization, qualification, and regulatory compliance from concept through commercialization while collaborating with engineering, manufacturing, biocompatibility, and product development teams.
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)
Benefits
- Remote work may be considered for exceptional qualifications for candidates residing in AZ, FL, GA, NJ, NC, TN, or TX.
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