Sr. Process Development Engineer
8 - 10 years experience • Medical Devices & Diagnostics
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.
Pushing the edge of what is possible give my work purpose. Different Reason. Same Mission. At Boston Scientific, it's personal.
About the role:
This position is responsible for the design and development of new and improved manufacturing processes and ensuring efficient and effective transfer of product into production. Core team member and site lead on a cross functional team of disposable medical devices. Looks to improve existing processes within the New Product Development project, that then may be shared across other lines. Manages and leads complex projects independently with minimal supervision
Develop and implement new manufacturing processes for new disposable medical devices. Perform Design of Experiments for process definition and to optimize equipment parameters for new and/or existing processes. Create documentation to support new and improved manufacturing processes. Use of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are ‘born lean and capable’. Write and perform process validations (IQ, OQ, PQ/PPQ) and validate methods for inspection for verification and process controls. Interface directly with assemblers, production supervisors, leads, engineers and management daily. Coordinate with the suppliers and external resources needed in developing and implementing new process/product plans.
Work as part of a development team in developing and implementing new devices. Facilitate excellent communications between all team members.
- Assesses process capabilities, innovates and implements process improvements on key projects with divisional impact.
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Executes the functional deliverables associated with the PDP, Design Control, CAPA, and all Quality Systems.
- As needed; plans, organizes, and participate all aspects of technical reviews.
- Collaborate to ensures proper documentation is completed to meet quality systems requirements. (e.g., GOIs, 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 and maintains qualified production lines.
- Provides Design for Manufacturability (DFM) and lean manufacturing inputs to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- Trains and/or provides work direction to technicians, and may train manufacturing personnel when required as part of a validation.
- Serves as a core team member on new product projects.
- Must comply with requirements of ISO 14001, Design Control, and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
- Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and appropriate regulations for the area they support.
- Participates in cross-functional teams.
- Collaborate to develop project planning, budgeting, scheduling and tracking.
- Analyzes problems in design, process and test development. Recommend/implement solutions.
- Ability to make and present engineering decisions.
- Collaborate in all aspects of Design Transfer and launching new process into operations; operator training, line set up, inventory, material presentation, build scheduling, and transferring responsibility to the manufacturing engineering support team.
May supervise or coach technicians, engineer or other support employees. Trains and/or provides work direction to direct reports, and may train manufacturing personnel when required as part of a validation.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
What we are looking for:
The position requires bachelors degree in science or BSME, MET, or related Engineering Degree and a minimum of seven (7) years medical device experience in process/manufacturing engineering role, three (3) of which have been in managing projects. Must have excellent mechanical aptitude, communication and interpersonal skills. Must be experienced in MS word, Excel and Project.
The ideal candidate will have previous experience in the areas of Design for Manufacturing (DFM), Lean Manufacturing, and Process Control Concepts, Design of Experiments (DOE), Software Validation, Technology/process Transfer experience, and product/process Failure Mode and Effects Analysis (FMEA). Use of Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma), and managing improvements through CAPA. Experience with CAD Software (Solid Works & AutoCAD) preferred.
Master’s degree in engineering and/or plastics processing experience a plus
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
Requisition ID: 366953