- FDA Regulations
- Technical Writing
- Statistical Software
- Analysis Skills
Additional Locations: US-RI-Coventry
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Process Engineer I
About the role:
The Process Engineer I is responsible for developing and maintaining capable processes and ensuring efficient and effective sterilization operation. This person will provide problem-solving skills to enable sterilization innovation while using technical and collaboration skills alongside his/her passion for innovation and continuous improvement to drive growth through efficient and effective process improvements.
Your responsibilities will include:
Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.
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.
Prepares and presents technical data and recommendations at technical reviews.
Writes and executes validation protocols and reports applicable to new/improved processes.
Ensures proper documentation is completed to meet quality systems requirements. (e.g., WI's, FMEA's, etc.)
Trains and/or provides work direction to technicians and may train manufacturing personnel when required as part of a validation.
Serves as core team member or extended team member on new product projects.
Provides ongoing production support for sterilization processes including troubleshooting, nonconformance investigation, and process improvements.
What we’re looking for in you:
Bachelor’s degree in Mechanical or Chemical Engineering.
0-2 years of experience.
Experience in a medical device industry focused on process characterization, process validation and working knowledge of validation methods, procedures, and equipment operation techniques.
Demonstrated use of DFSS tools (DOE, problem solving, statistical analysis)
Demonstrated cross functional teamwork in technically demanding environment.
Proven use of problem solving skills to address issues of moderate scope and complexity with understanding of business impact
Highly motivated individual that can independently drive deliverables to completion through collaboration among team members (internal and externally)
Proficient technical writing experience in a similar industry, preferred in medical device
Experience in statistical software systems, preferably Minitab.
Experience with PLC-based systems and process control a plus
Good working knowledge of medical device manufacturing requirements and FDA/ISO compliance guidelines.
Possesses strong analytical skills and hands-on experience with manufacturing equipment and processes.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 461130
Nearest Major Market: Providence
Nearest Secondary Market: Rhode Island
Job Segment: Process Engineer, Medical, Manufacturing Engineer, Engineer, Medical Technology, Engineering, Healthcare