Job Description

Position Overview:

The Fiber Optic R&D Engineer will have experience in optical fiber technologies for medical device applications. Ideal candidate will possess knowledge of fiber processing techniques and the ability to develop and optimize manufacturing processes to enhance product performance, reliability, and manufacturability. Additionally, The Fiber Optic R&D Engineer will use engineering knowledge to design, develop, verify and validate product designs in support of companys strategic plan. Contribute as part of a crossfunctional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing.

Responsibilities:

Responsibilities:

• Process Development: Through hands-on technical execution, develop, optimize, and validate optical fiber manufacturing processes, including polishing, cleaving, splicing, ferrule inspection, coupler / combiner / splitter assembly, glass processing, and sensor fabrication. Supports with efforts to scale processes from development to full scale manufacturing.
• Equipment Utilization: Operate and maintain state-of-the-art fiber processing equipment, including Fujikura cleavers and splicers, Domaille polishers, glass processors, fiber inspection scopes, and Keyence microscopes.
• Technical Expertise: Provide knowledge of various fiber types (single-mode and multimode), fiber coatings, clad thicknesses, and materials. Ensure compliance with industry standards and best practices.
• End Face Processing: Design, optimize, and implement end face fiber processing techniques.
• Connector Knowledge: Demonstrate knowledge in common fiber connectors, including single fiber ceramic ferrules, multi fiber ferrules (MT), and linear ferrule arrays, to enhance assembly and reliability. Demonstrate competence in ferrule polishing and polishing recipe development.
• Testing and Validation: Demonstrate knowledge of optical test configurations for launching light into fibers, measuring light transmission, and conducting performance evaluations.

Analyze data to drive continuous improvement initiatives. Performs or manages process validations (IQ/OQ, OQ, PQ).

Perform Verification and Validation (V&V) and may draft protocols/reports for approval.

Conducts testing to verify that the design meets the engineering specifications.

• Collaboration: Work closely with cross-functional teams, including R&D, quality assurance, and production, to ensure alignment on process development goals and product specifications.
• Documentation and Reporting: Prepare and maintain detailed documentation of processes, test results, and validation protocols. Present findings to stakeholders and contribute to technical reports. Draft design transfer documentation.

Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.).

Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities.

Document engineering work in compliance with the company's quality system.

• Continuous Improvement: Evaluate current catheter manufacturing practices and identify those needing improvement. Use lean manufacturing techniques to maximize manufacturability.
• Statistical Analysis: Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.Compiles and analyzes data to identify root causes, draw conclusions, generate solutions, and generate reports.
• Risk Mitigation: Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis.
• Design: Able to design process fixtures and tools. Support the development of specifications for tooling and fixturing according to company quality standards.

Qualifications:

Education:

• Engineering degree desired or equivalent experience in related job field

1. Required Experience:

• 0-2 yrs (Engineer I) or 2+ yrs (Engineer II) Biomedical product / medical device development or fiber optic device assembly / development experience.
• Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
• Proficient in CAD software, preferably SolidWorks.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
• Understanding of IEC60601 requirements/constraints for mechanical system design is preferred.
• Hands-on experience managing suppliers and/or contract manufacturers a plus.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred.
• Experience with fiber optic processing including cleaving, tapering, fusion splicing, and terminating / polishing ferrules.

Knowledge, Skills, and Abilities:

• Proficient in Risk Management according to ISO 14971.
• Knowledge of ASME Y14.5 GD&T.
• Excellent interpersonal, communication, and documentation skills are required.
• Takes initiative and acts quickly to drive solutions.
• Strong interpersonal, organizational and communication skills.
• A flexible team player, focusing on shared goals with a positive resultsoriented attitude.

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