Staff/Principal Process Development Engineer

3 days ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.


Overview:

We are seeking an experienced Senior to Principal Process Development Engineer specializing in optical fiber technologies for medical device applications. The ideal candidate will possess extensive knowledge of fiber processing techniques and the ability to develop and optimize manufacturing processes to enhance product performance, reliability, and manufacturability.

Responsibilities:

  • Process Development: Lead the development, optimization, and validation of optical fiber manufacturing processes, including polishing, cleaving, splicing, and ferrule inspection. Leads scaling up processes from development to full scale manufacturing.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • Design: Able to design process fixtures and tools.


Qualifications:

Education & Experience:

  • Bachelor’s degree in Optical Engineering, Materials Science, Mechanical Engineering, or a related field; a Master’s degree or Ph.D. is preferred.
  • Minimum of 8 years of relevant experience in optical fiber process development. Minimum of 3 years in regulated industry (medical or aerospace).

Technical Skills:

  • Expertise in fiber processing techniques: polishing, cleaving, splicing, tapering, and cleaning.
  • Familiarity with fiber tapering, end face fiber angled cleaves, lensing, fiber combiners and splitters is a plus.
  • Proficient in the use of advanced optical fiber equipment.

Knowledge Base:

  • In-depth understanding of fiber types, coatings, clad thickness, and material properties.
  • Familiarity with common fiber connectors and their applications.

Analytical Skills:

  • Independent critical thinker with strong problem-solving abilities and a scientific approach to process optimization and testing.

Communication:

  • Excellent verbal and written communication skills, with the ability to present complex technical information clearly.

Software: Experience in Zemax, Solid Works, MiniTab, MS Project, MS applications


This position may be hired at a Senior Engineer or Principal Engineer level. Salary ranges are: $110K-$140K for Senior and $130K-$160K for Principal. Level and salary range will be determined based on experience and qualifications.

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