Additional Location(s): N/A
About the role:The Manufacturing Engineer I supports manufacturing operations through process development, process improvement, equipment implementation and production support activities. This role partners with Operations, Quality, R&D, Supply Chain and Regulatory Affairs to help ensure products are manufactured safely, efficiently and in accordance with applicable quality system requirements.
The Manufacturing Engineer I contributes to the development, validation and continuous improvement of manufacturing processes while building technical expertise in medical device manufacturing, Lean Manufacturing and process validation methodologies.
Work model, sponsorship, relocation:This is an on-site role requiring employees to work from our Carlsbad, California office to support hands-on manufacturing operations and cross-functional collaboration. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your responsibilities will include:- Provide day-to-day engineering support for catheter manufacturing operations.
- Investigate manufacturing issues and support corrective actions that improve product quality, yield, throughput, and productivity.
- Support the evaluation and disposition of nonconforming material and production-related quality issues.
- Assist with root cause investigations and contribute to NCR, CAPA, deviation, and failure investigation activities.
- Evaluate existing manufacturing processes and identify opportunities to improve safety, quality, delivery, cost, and capacity.
- Analyze workflows, equipment utilization, assembly methods, and manufacturing sequences to improve operational efficiency.
- Participate in Lean Manufacturing initiatives, including Value Stream Mapping, Kaizen events, 5S, and waste-reduction projects.
- Support manufacturing process development, implementation, and continuous improvement activities.
- Support equipment qualification and process validation activities, including IQ, OQ, and PQ.
- Assist with Test Method Validation activities and inspection method development.
- Support change control activities and assess potential impacts to manufacturing processes and validated systems.
- Create and revise controlled manufacturing documentation, including Manufacturing Process Instructions, work instructions, validation protocols and reports, engineering studies, equipment procedures, process flows, routings, and bills of material.
- Collaborate with Operations, Quality, R&D, Supply Chain, and Regulatory Affairs on production support, design transfer, commercialization, supplier readiness, and process improvement activities.
- Participate in risk management and process-development activities, including process flow reviews and PFMEA updates.
- Complete assigned engineering projects with clear documentation, data analysis, and communication of results.
Required Qualifications:- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, Materials Engineering, or a related engineering discipline.
- Zero to three years of engineering experience in manufacturing, medical devices, life sciences, or another regulated industry. Internship, cooperative education, or equivalent manufacturing experience is preferred.
- Basic understanding of manufacturing processes, production environments, and engineering problem-solving methods.
- Familiarity with statistical analysis, data-driven decision making, and Lean Manufacturing principles.
- Familiarity with medical device quality systems, design controls, change control, CAPA, and ISO 13485 or FDA-regulated manufacturing is preferred.
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
- Experience with Minitab, SolidWorks, ERP/MES systems, or manufacturing documentation systems is a plus.
- Strong analytical, organizational, written communication, and interpersonal skills.
- Ability to work effectively both independently and within cross-functional teams.
- Demonstrated initiative, willingness to learn, and a continuous improvement mindset.
Requisition ID: 633599Minimum Salary: $ 62800 Maximum Salary: $ 119300 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will 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.
