Bolt Medical ยท 2 months ago
Sr. and Staff Fiber Optic R&D Engineer
Carlsbad, CA
Full-time
Onsite
Senior Level, Lead/Staff
$140K/yr - $165K/yr
3+ years expBolt Medical is focused on advancing medical device technologies, and they are seeking a Senior Fiber Optic R&D Engineer to lead the development and optimization of optical fiber manufacturing processes. The role involves collaborating with cross-functional teams to support product design, development, and validation for therapeutic medical devices.
ManufacturingMedicalMedical Device
Hiring Manager
Dania Cital
Responsibilities
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
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
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
Provide in-depth knowledge of various fiber types (single-mode and multimode), fiber coatings, clad thicknesses, and materials
Design, optimize, and implement end face fiber processing techniques
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
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
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
Conduct testing to verify that the design meets the engineering specifications
Work closely with cross-functional teams, including R&D, quality assurance, and production, to ensure alignment on process development goals and product specifications
Create and manage a schedule of technical deliverables in coordination with a project manager
Provide training and guidance to technicians and less experienced engineers
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
Evaluate current catheter manufacturing practices and identify those needing improvement. Use lean manufacturing techniques to maximize manufacturability
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
Identify hazards and mitigate risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis
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
Qualification
Required
Engineering degree desired or equivalent experience in related job field
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
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)
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
Hands-on experience managing suppliers and/or contract manufacturers
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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