Boston Scientific Senior Process Engineer 

United States, Minnesota 

154042885

Your responsibilities will include:

• Demonstrate strong technical expertise on process/product technologies to support selection, design, optimization, validation, and troubleshooting of, and can mentor engineers and technicians in problem resolution on, those technologies
• Liaise with Equipment Engineering or external equipment/tooling or material vendors in the selection, design, and development of new (or upgrades to existing) equipment, tooling, and materials
• Demonstrate strong knowledge of DMAIC tools and apply these tools in the characterization, optimization, and troubleshooting of process equipment and technology performance
• Lead the development and execution of experimentation and testing to enable characterization, optimization, and troubleshooting of key processes and equipment; summarize, analyze, and draw conclusions from test results leading to effective technical resolution
• Coordinate the introduction of new processes, equipment, and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions
• Demonstrate strong knowledge and application of Lean methodologies and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost-effective equipment and processes
• Demonstrate strong knowledge and application of Process and equipment validation techniques, PFMEAs, and associated regulatory requirements; apply this knowledge in the efficient & timely validation of equipment and processes
• Complete or lead the writing and release of process validation documentation including FMEAs, Validation Plans, protocols, and reports
• Coordinate execution and documentation of validation builds; coordinate testing of validation units and the compilation, analysis, and reporting of the validation results
• Demonstrate a primary commitment to patient safety and product quality
• Understand and comply with all the regulations governing the quality systems

Required qualifications:

• Bachelor’s degree in an engineering field
• 6+ years of experience in related engineering role or related field
• Experience with Extrusion processing
• Validation experience (IQ/OQ/PQ, etc.)
• Experience in process development (process improvement, etc.)
• Hands on Mechanical aptitude and strong problem-solving skills

Preferred qualifications:

• Experience with Silicon Ram Extrusion
• Validation experience specifically within the medical device field or other highly regulated industry
• Experience with DFM, DMAIC, PLCP, DOE, SolidWorks, PDP/TDP

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.