The R & D Engineer plans and executes material engineering and technology projects related to the design and manufacture of medical devices. This position will focus in the manufacturing process development that will lead to the removal of hazardous substances as defined by EU/MDR 2017/745 and compliance of the Business Unit CE marked medical devices to the new MDR and revised ISO standards.
• Lead projects in the redesign or replacement of materials defined as hazardous by the EU MDR 2017/745
• Interface with Suppliers, Procurement function, Quality and Regulatory Affairs to deliver projects.
• Plan and lead manufacturing process validation activities for new/replacement of materials as per product requirements.
• Interface with suppliers to obtain quotations, purchase components, and debug problems with replacement parts.
• Interface with relevant Functions to obtain device samples for testing
• Implement the product-level material change plans related to satisfying product design specifications, verification and validation activities including product performance, biocompatibility validations and usability studies or evaluations. Leverage data and testing across products and applications where possible.
• Coordinate and implement laboratory testing, data analysis and preparation of technical reports.
• Collaborate with the required internal process experts and process engineering and Quality and Regulatory teams to execute the new material implementation plan.
• Ensure projects are developed and documented compliant with the Quality System Design control requirements
• Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
This position will be based @ Tecate BC
• Bachelor of Science in Mechanical or Biomedical Engineering preferred; other technical disciplines considered
• Previous experience in similar role in medical Industry is a MUST.
• 3+ years previous experience in related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics)
• Experience with extrusion and blow-molding processes preferred.
• Strong analytical, technical and problem-solving skills.
• Previous experience in design of medical devices preferred.
• Hands-on experience preferred.
• Effective verbal and written communication skills.
• Team player with good interpersonal skills.
• Proficient in Microsoft Office Suite and SolidWorks or equivalent modeling system; familiar with statistical analysis (Minitab) and computerized analysis (FEA) applications.
• Experience in SolidWorks CADD (design/drafting) program
• Microsoft Office Suite, (Project, Word, Excel and Access)
• Injection molding, plastic extrusion and plastic part assembly process and methods
• U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices
• ISO and ASTM testing methods for medical devices and general plastic components
• Principles and practices of professional engineering
• Regulations pertaining to medical device design and design modifications
• Strong written and verbal communication skills and attention to detail.
• Effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
• Analyze complex, technical and administrative problems and adopt an effective course of action.
|Edad||Mayor de 26 años|
|Horario||Lunes a Viernes 7:00 a 5:00|
|Sueldo||Negociable de acuerdo a experiencia.|