Quality Engineer II Job

Additional Locations: (n/a); US-IN-Evansville; US-IN-Fort Wayne; US-IN-Gary/Merrillville; US-IN-Indianapolis; US-IN-Lafayette; US-IN-South Bend; US-IN-Spencer; US-IN-Terre Haute



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 are hiring for multiple positions***


About the role:

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provide focused quality engineering support operational, or system/services support. 


Your responsibilities will include:

New Process / Product Development activities:

  • Develop and/or provide support on new/existing Quality Plan, Product Bio Rationale, Hazard Analyses, and FMEA (Design and Process)
  • Review and/or document Design Control Activities such as Project Phase Reviews, Marketing and Product Spec Reviews, Regulatory compliance, Packaging and Sterilization Waivers and Logistics of Pilot runs
  • Conduct/Support Biocompatibility and Age Testing & Activities, Product Release and Update tech files
  • Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE),  production control plans
  • Provide direction in implementing First Article Inspection, In-Process Inspection, Sampling Plan, product/components testing, inspection and acceptance criteria


Other Duties /Activities:

  • Provides leadership role on championing departmental or cross-functional engineering initiatives.
  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Mentor for technical guidance for identifying and resolving quality issues.
  • Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Proactively investigate and analyze customer complaints.
  • Must comply with requirements of ISO 14001 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 the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.


What we’re looking for in you:

Basic Qualifications

  • 2- 4 years’ experience with a BS in Engineering or related discipline. 1-3 years medical device experience required. 
  • Demonstrated used of Quality tools/methodologies including  SPC, DOE, GR&R, FMEA, CAPA, complaint investigation, process validation (IQ, OQ,PQ) and FDA, ISO/MDD standards.
  • Demonstrated interpersonal skills with ability to work within a team environment. 
  • Strong written/verbal communication skills. 
  • Proficiency in all Microsoft Office programs.


Preferred Qualifications

  • Experience in First Article and Acceptance Activities
  • Experience in Test Method Validation
  • Six sigma problem solving methodologies
  • Proficiency in MINITAB Statistical Software


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: 415015


Boston Scientific
Full time
Spencer, Indiana 47460, US