Manufacturing Engineer I

Boston Scientific • Carlsbad, CA

2d • $62,800 - $119,300 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Internship, cooperative education, or equivalent manufacturing experience is preferred.
• Familiarity with medical device quality systems, design controls, change control, CAPA, and ISO 13485 or FDA-regulated manufacturing is preferred.
• Experience with Minitab, SolidWorks, ERP/MES systems, or manufacturing documentation systems is a plus.

Responsibilities

• 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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level