Boston Scientific Senior Process Development Engineer 

United States, Minnesota, Maple Grove 

729798296

Works cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of product into production.

Your responsibilities will include:

• Developing new process capabilities and owning the development of critical processes for a complex device in a pilot environment.
• Collaborating & partnering with R&D to develop product concepts, influence design specifications and provide Design for Manufacturability (DFM) input to the engineering print package.
• Driving successful prototyping of various design configurations in a development pilot line environment.
• Works cross functionally to lead, own, develop, & deliver capable and robust processes and equipment to operations.
• Develops experimental strategy and presents technical data to drive recommendations at technical reviews.
• Solving complex technical problems in a hands-on manner, working in a fast-paced environment.
• Providing structured, technical leadership and problem solving to product and process innovation.
• Lead a strategic process development cycle through Pilot, Design Verification and Commercialization for the Watchman Implant.
• Develop, write, & review process validation strategy and related deliverables to meet quality system requirements. (e.g., Experiment tech reports, GR&R, TMV, IQ, FMEA’s, etc.) .
• Contributes ideas to or generates Intellectual Property submissions.
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
• Plans, organizes, and conducts all aspects of technical reviews.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
• Writes and reviews validation protocols and reports applicable to new processes.
• Oversees development builds associated with the project using special work requests.
• Develops qualified production lines.
• Provides Design for Manufacturability (DFM) input to the engineering print package.
• Contributes ideas to or generates Intellectual Property submissions.
• Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
• May serve as a core team member or extended team member on new product projects.

Required qualifications:

• Minimum of 5 years of experience
• Bachelor’s Degree in engineering or relevant technical field

Preferred Qualifications:

• Experience providing technical leadership in a fast paced development environment
• Experience with Nitinol Manufacturing and complex equipment
• Demonstrated cross functional collaboration and influence in a technical environment
• Demonstrated understanding and usage of statistics to drive improvements
• Experience with Process Verification and Validation
• Experience with equipment qualification and implementation
• Experience in Designed Experimentation
• Medical device or other regulated industry experience
• Demonstrated understanding of problem solving and root cause investigations
• Expertise in Operations and/or New Product Development
• Experience with Test Method Validation
• Excels in a collaborative, cross-site environment
• Potential for travel up to 10% of their time

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.