Bolt Medical
Sr. and Staff Fiber Optic R&D Engineer
Bolt Medical, Carlsbad, California, United States, 92002
Base pay range: $140,000.00/yr - $165,000.00/yr
Full-time, Mid-Senior level, Engineering and Information Technology
The Sr. Fiber Optic R&D Engineer will develop and optimize optical fiber manufacturing processes for medical device applications. They will lead process development, design and develop therapeutic medical devices, support product transfer to manufacturing, and collaborate cross‑functionally.
Responsibilities
Process Development : 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—scaling up to full‑scale manufacturing.
Process Management : Manage processes and ensure activity goals are achieved.
Development Team Representation : Represent Process Engineering in R&D and project meetings, providing technical expertise and support for analytical methods, validation, scale‑up, and manufacturing capabilities.
Equipment Utilization : Operate and maintain state‑of‑the‑art fiber processing equipment (Fujikura cleavers/splicers, Domaille polishers, glass processors, fiber inspection scopes, Keyence microscopes).
Technical Expertise : Provide in‑depth knowledge of fiber types, coatings, clad thicknesses, and materials; ensure compliance with industry standards.
End Face Processing : Design, optimize, and implement end‑face fiber processing techniques.
Fiber Optic Sensors : Fabricate/process fiber optic sensors for imaging, pressure, temperature, acoustic/vibrations; fabricate ball lenses and polish fibers/lenses.
Connector Knowledge : Expertise in common fiber connectors (single‑fiber ceramic ferrules, multi‑fiber ferrules, linear ferrule arrays); develop ferrule polishing recipes.
Testing & Validation : Set up optical test configurations, measure light transmission, evaluate performance, analyze data, and conduct process validations (IQ/OQ, OQ, PQ).
Verification & Validation (V&V) : Perform testing to verify designs and draft protocols/reports for approval.
Collaboration : Work closely with R&D, QA, and production to align on process goals and product specifications.
Documentation & Reporting : Prepare and maintain detailed process documentation, test results, validation protocols, design transfer documents, and support the quality system.
Continuous Improvement : Evaluate manufacturing practices, use lean manufacturing techniques, Six Sigma methodologies (DMAIC/DMADV), Minitab, FMEA, fishbone charts, process mapping.
Risk Mitigation : Identify hazards, conduct risk analysis, support Design and Process FMEA.
Design : Design process fixtures and tools, specify tooling and fixturing to quality standards, support new product and revision designs.
Qualifications Education : Engineering degree desired or equivalent experience.
3+ (Sr.) or 5+ (Staff) years of relevant optical fiber process development experience, preferably in medical device or biomedical product development.
Experience with fiber optic processing (cleaving, tapering, fusion splicing, ferrule terminating/polishing).
Working knowledge of mechanical design principles and FDA‑regulated medical device design controls.
Proficient in CAD (SolidWorks preferred).
Statistical analysis skill with Minitab preferred.
Familiarity with IEC 60601 requirements for mechanical design.
Experience managing suppliers/contract manufacturers.
Strong cross‑functional collaboration, influence without authority, and project management.
Self‑starter who handles critical issues and ambiguous requirements.
Hands‑on mechanical prototyping, verification, and failure analysis.
Knowledge of design control (21 CFR 820, ISO 13485), ECO, CAPA.
Knowledge, Skills, and Abilities
Proficient in risk management (ISO 14971).
Knowledge of ASME Y14.5 GD&T.
Excellent interpersonal, communication, and documentation skills.
Initiative and drive solutions quickly.
Strong organizational and communication skills.
Flexible team player with positive results‑oriented attitude.
Skilled problem solver, proficient in problem‑solving methodologies.
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
Full-time, Mid-Senior level, Engineering and Information Technology
The Sr. Fiber Optic R&D Engineer will develop and optimize optical fiber manufacturing processes for medical device applications. They will lead process development, design and develop therapeutic medical devices, support product transfer to manufacturing, and collaborate cross‑functionally.
Responsibilities
Process Development : 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—scaling up to full‑scale manufacturing.
Process Management : Manage processes and ensure activity goals are achieved.
Development Team Representation : Represent Process Engineering in R&D and project meetings, providing technical expertise and support for analytical methods, validation, scale‑up, and manufacturing capabilities.
Equipment Utilization : Operate and maintain state‑of‑the‑art fiber processing equipment (Fujikura cleavers/splicers, Domaille polishers, glass processors, fiber inspection scopes, Keyence microscopes).
Technical Expertise : Provide in‑depth knowledge of fiber types, coatings, clad thicknesses, and materials; ensure compliance with industry standards.
End Face Processing : Design, optimize, and implement end‑face fiber processing techniques.
Fiber Optic Sensors : Fabricate/process fiber optic sensors for imaging, pressure, temperature, acoustic/vibrations; fabricate ball lenses and polish fibers/lenses.
Connector Knowledge : Expertise in common fiber connectors (single‑fiber ceramic ferrules, multi‑fiber ferrules, linear ferrule arrays); develop ferrule polishing recipes.
Testing & Validation : Set up optical test configurations, measure light transmission, evaluate performance, analyze data, and conduct process validations (IQ/OQ, OQ, PQ).
Verification & Validation (V&V) : Perform testing to verify designs and draft protocols/reports for approval.
Collaboration : Work closely with R&D, QA, and production to align on process goals and product specifications.
Documentation & Reporting : Prepare and maintain detailed process documentation, test results, validation protocols, design transfer documents, and support the quality system.
Continuous Improvement : Evaluate manufacturing practices, use lean manufacturing techniques, Six Sigma methodologies (DMAIC/DMADV), Minitab, FMEA, fishbone charts, process mapping.
Risk Mitigation : Identify hazards, conduct risk analysis, support Design and Process FMEA.
Design : Design process fixtures and tools, specify tooling and fixturing to quality standards, support new product and revision designs.
Qualifications Education : Engineering degree desired or equivalent experience.
3+ (Sr.) or 5+ (Staff) years of relevant optical fiber process development experience, preferably in medical device or biomedical product development.
Experience with fiber optic processing (cleaving, tapering, fusion splicing, ferrule terminating/polishing).
Working knowledge of mechanical design principles and FDA‑regulated medical device design controls.
Proficient in CAD (SolidWorks preferred).
Statistical analysis skill with Minitab preferred.
Familiarity with IEC 60601 requirements for mechanical design.
Experience managing suppliers/contract manufacturers.
Strong cross‑functional collaboration, influence without authority, and project management.
Self‑starter who handles critical issues and ambiguous requirements.
Hands‑on mechanical prototyping, verification, and failure analysis.
Knowledge of design control (21 CFR 820, ISO 13485), ECO, CAPA.
Knowledge, Skills, and Abilities
Proficient in risk management (ISO 14971).
Knowledge of ASME Y14.5 GD&T.
Excellent interpersonal, communication, and documentation skills.
Initiative and drive solutions quickly.
Strong organizational and communication skills.
Flexible team player with positive results‑oriented attitude.
Skilled problem solver, proficient in problem‑solving methodologies.
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr