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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
About the role:Boston Scientific is looking for a Fiber Optics R&D Engineer. This person will have experience in optical fiber technologies for medical device applications. Ideal candidate will possess knowledge of fiber processing techniques and the ability to develop and optimize manufacturing processes to enhance product performance, reliability, and manufacturability. Additionally, the Fiber Optic R&D Engineer will use engineering knowledge to design, develop, verify and validate product designs in support of company's strategic plan. Contribute as part of a cross-functional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing.
Work Mode:At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be present in our Carlsbad, CA office, at least four to five days per week.
Visa Sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include:
- 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.
Required qualifications:- 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 qualifications:- 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.
Requisition ID: 618929 Minimum Salary: $ 61000 Maximum Salary: $ 115900 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for
non-exempt (hourly), non-sales roles 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).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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