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Boston Scientific · 4 days ago

Fiber Optics R&D Engineer I

Carlsbad, CA

Full-time

Onsite

New Grad, Entry Level

$61K/yr - $116K/yr

0+ years exp

Boston Scientific is a leader in medical science, committed to solving health industry challenges. They are seeking a Fiber Optics R&D Engineer to develop and optimize manufacturing processes for optical fiber technologies in medical devices, collaborating with cross-functional teams to ensure product performance and reliability.

Health CareMedicalMedical Device

No H1B

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

Qualification

Optical fiber technologiesFiber processing techniquesManufacturing process optimizationCAD software (SolidWorks)Statistical analysis (Minitab)Risk Management (ISO 14971)Design control (ISO 13485)Interpersonal skillsCommunication skillsDocumentation skillsTeam collaboration

Required

Engineering degree desired or equivalent experience in related job field

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

Preferred

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 results‐oriented attitude

Benefits

Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).