Bolt Medical · 2 months ago
Fiber Optics R&D Engineer I & II
Carlsbad, CA
Full-time
Onsite
New Grad, Entry, Mid Level
$80K/yr - $120K/yr
0+ years expBolt Medical is focused on developing innovative medical devices, and they are seeking a Fiber Optics R&D Engineer to enhance product performance through optical fiber technologies. The role involves process development, testing, and collaboration with cross-functional teams to ensure product specifications are met and processes are optimized for manufacturing.
ManufacturingMedicalMedical Device
Hiring Manager
Dania Cital
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
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
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
Preferred
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
Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred
Company
Bolt Medical
Bolt Medical develops medical devices like the investigational Bolt IVLTM System, focusing on healthcare solutions.
51-200 employees
H1B Sponsorship
Bolt Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Boston Scientific
2025-01-08Acquired
2019-01-01Corporate Round
Recent News
San Diego Union-Tribune
2025-11-28
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