Job Description

Position Overview:

The Sr. 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 Sr. Fiber Optic R&D Engineer will be a key contributor to the design and development of a therapeutic medical device, from concept to early human use to pivotal trial readiness. 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.

Position Overview:

• Process Development: Through hands-on technical execution, lead the development, optimization, and validation of optical fiber manufacturing processes, including polishing, cleaving, splicing, ferrule inspection, coupler / combiner / splitter assembly, glass processing, and sensor fabrication. Leads scaling up processes from development to full scale manufacturing.

Manages processes and ensures that activity goals are achieved.

• Development Team: Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing.

Successful completion of engineering work in product design and development, test methods, research investigation (animal and clinical studies), and report preparation.

• 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 in-depth 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.
• Fiber Optic Sensors: Demonstrate expertise in fiber optic sensor technologies, applications, and fabrications including sensors for imaging, pressure, temperature, and acoustic / vibrations.Ability to fabricate / process ball lenses and polish fibers / lenses.
• Connector Knowledge: Demonstrate expertise 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: Set up 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.

Creates and manages a schedule of technical deliverables in coordination with a project manager.

Provides training and guidance to technicians and less experienced engineers.

• 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. Translates highly technical results into easily understandable recommendations that will influence cross-functional and senior stakeholders.
• 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.
• Work with engineers and QA to create designs for new products, product revisions, components, assemblies, or tools.

Qualifications:

Education:

• Engineering degree desired or equivalent experience in related job field

1. Required Experience:

• 3+ (Sr.) or 5+ (Staff) years of relevant experience in optical fiber process development preferably in medical device industry or biomedical product / medical device development.
• Experience with fiber optic processing including cleaving, tapering, fusion splicing, and terminating / polishing ferrules.
• Working knowledge of mechanical design principles and FDA regulated medical device design controls.
• 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.
• Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project team.
• Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
• Excellent hands-on mechanical prototyping, verification, and failure analysis skills.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA).

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.
• Skilled problem solver, proficient in problem solving methodologies

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