Principal Engineer – Disposables R&D, Sustaining
Job Summary (Principal Engineer – Disposables R&D, Sustaining)
• Lead design and development of product changes for disposable medical devices within a sustaining engineering context.
• Schedule, budget, and lead engineering projects with minimal guidance.
• Serve as technical expert for design change programs, including new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
• Identify, investigate, and solve complex engineering problems using risk-based, customer-focused approaches and engineering tools (e.g., dFMEA, Human Factors Engineering, statistical software, CAD).
• Lead creation and maintenance of design history files.
• Coordinate and communicate R&D efforts with global cross-functional stakeholders.
• Ensure adherence to design control procedures, safety rules, company policies, FDA/international regulations, and guidance.
• May supervise engineers and/or technicians.
• Potentially contribute to intellectual property through invention disclosures and patent applications.
• Apply advanced knowledge of plastics materials and processing (injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization).
• Utilize advanced understanding of FDA Design Controls, ISO 13485, and risk management (ANSI/AAMI/ISO 14971).
• Work with CAD and PDM enterprise software (e.g., Creo, SolidWorks).
• Employ creative problem-solving to identify risks, develop mitigations, and guide the team to overcome obstacles.
• Requires a Bachelor’s (MS preferred) in Mechanical, Plastics, Biomedical Engineering, or related field, and 5-8 years’ experience in Class II/III disposable medical product development.
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