Senior Process Development Engineer

Boston Scientific   •  

Spencer, IN

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 115 days ago

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.

 ***We have multiple openings

 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.  Seeks to improve existing processes within the New Product Development project that then may be shared across other lines.  Manage and leads complex projects independently with minimal supervision.

 Your responsibilities will include: 

  • 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.
  • Work as part of a development team to create 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. 
  • Assesses process capabilities, innovates and implements process improvements on key projects with divisional impact.
  • Collaborate to ensures proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOM’s, Routers, FMEA’s, etc.)
  • Provides Design for Manufacturability (DFM) and lean manufacturing inputs to the engineering print package.
  • 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.
  • 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.

       

What we’re looking for in you:

 Basic Qualifications 

  • The position requires Bachelor’s degree in science or BSME, MET, or related Engineering Degree and a minimum of 5 years’ medical device experience in process/manufacturing engineering role, three 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.

 

Preferred Qualifications

  • 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

  • About us

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: 415062