Quality Engineer II

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

This Quality Engineer II role will provide support for Molding & Men’s Health production operations at the Arden Hills site. An individual stepping into this role will help ensure delivery of the highest quality result to the customer, while supporting continuous improvement projects and quality initiatives. They will partner with a broader team to accomplish day-to-day floor support, proactive problem solving, NC dispositions, and NCEP/CAPA work. Additionally, this person will support value improvement projects, and Workstation Vulnerability Assessment efforts. In a fast-paced and dynamic environment, a Quality Engineer in this division would be a process owner for manufacturing line(s), working cross-functionally with their manufacturing engineering and production counterparts to achieve business goals. The ideal candidate for this position will be comfortable interfacing with downstream internal customers and providing quality leadership to the production team. 

Your responsibilities will include:

• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
• Develops product quality plans, documents, and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
• Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation to reduce/eliminate the cause of defects.
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.   Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
• Responsible for the final Process Monitor Release for products prior to distribution.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Perform process validation and verification activities and generate/review related documentation.
• Identifies possible sources of manufacturing defects and devises methods to reduce process variation to reduce/eliminate the cause of defects
• Collects and analyzes process defect data for product/process improvement efforts (e.g., scrap, nonconforming product, customer complaints) 
• Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation
• Participates in team decision making and displays team problem solving/communication skills.

Required qualifications:

• Bachelor’s degree in engineering with 2+ years of experience in a Quality, Manufacturing Engineering, R&D or NPI role

or

• Master’s degree in engineering with 1+ years of experience in a Quality, Manufacturing Engineering, R&D or NPI role

Preferred qualifications:

• Medical device experience
• Experience in molding and silicone related materials
• Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
• Experience in Validation, Statistical sampling and/or Root Cause Investigation
• Familiarity with product documentation, inspection and testing, and Manufacturing Execution
• Problem Solving Certification (Green Belt, CQE, Six Sigma, etc.).

Requisition ID: 583126

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.