Sr. Manufacturing Engineer

About the role

Manufacturing Engineer III works closely with the R&D team to implement the newly developed processes in manufacturing. Plans and designs manufacturing processes for a production facility. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and workforce utilization. Manufacturing Engineer III determines the parts, equipment, and tools needed to achieve manufacturing goals according to product specifications and provides mentorship to other manufacturing engineers and technicians.

This position will follow an onsite schedule, requiring 5 days in-office per week from our Carlsbad, CA site.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Evaluate current console manufacturing practices and identify those needing improvement.
• Lead operations to increase production capacity and implement new efficient processes.
• Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel.
• Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events.
• Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.
• Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity.
• 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.
• Performs or manages process validations (IQ/OQ, OQ, PQ).
• Troubleshoot production line issues related to yield, quality, and throughput.
• Leads scaling up processes from development to full scale manufacturing.
• Supports evaluation of NCR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers/Suppliers.
• Creates/Updates manufacturing instructions, routings, bills of materials and SOPs and performs training when required.

• M.S Engineering degree desired or equivalent experience in related job field
• 5+ yrs (Engineer II) Biomedical product or medical device development experience.
• Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
• Proficient in CAD software, preferably Solid Works.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab 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.
• 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.

• Proficiency in Minitab
• Hands‑on experience managing suppliers and/or contract manufacturers a plus.

Requisition

Minimum Salary: $86600

Maximum Salary: $164500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — 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…