Senior Process Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At 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:  

 

This Senior Process Engineer position is part of the Process Development team within Boston Scientific based in Maple Grove, MN, USA. This position’s primary role includes exploring and developing extrusion-based technology to lead towards manufacturing high DFM processes through our PLCP (Product Life Cycle Process). This Senior Process Engineer role is within our diverse, highly dynamic, and rapidly growing Components team specifically focused on Extrusion processing where we support all divisions (Interventional Cardiology, Peripheral interventions, Endoscopy, Urology, WATCHMAN, etc.). The purpose of this role is to work closely with R&D and Manufacturing in the development of robust, capable, cost-effective, & safe manufacturing processes. equipment, materials, and products and support efficient and effective transfer of new products & processes into commercial production.

 

At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week.

 

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

 

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