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.
Quality Engineer II – Design Assurance, Sustaining Engineering
About this role:
A Design Assurance Quality Sustaining Engineer II is responsible for assuring all requirements are met for the Product Lifecycle Process (PLCP), Risk Management, Design Controls and Usability Testing in support of sustaining and improving current products on the market. Works in fast paced Cross-Functional Teams to maintain and support 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 assigned departmental, functional, site, divisional and corporate quality goals and priorities.
Your responsibilities include:
What we’re looking for in you:
- Product Support: Provide key quality trending information and data for Management Review and Complaint Reviews. Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s, PIR’s and Field Actions
- Champion Continuous Improvement: Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Lead the implementation activities for post-market surveillance, product feedback and corrective and preventive action programs. assurances, process controls, and CAPAs / systems designed to meet or exceed internal and external requirements.
- Design Controls: Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
- Audit Support : Support internal and external regulatory audits in a research capacity.
A commitment to our Vision to be a trusted design partner of choice that uses our specialized knowledge to deliver quality results for our customers by being Engaged, Communicative, Thoughtful, Proactive, Trustworthy and a Steward of Best Practice.
Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering. MS degree preferred.
Minimum of 3 years of Medical Device design controls and risk management experience required.
In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product design & development and product risk management.
Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EUMDR, EN ISO 13485, and EN ISO 14971.
Strong communication (oral and written) and presentation skills.
Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
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
Nearest Major Market:
Quality Engineer, Medical, Engineer, Electrical, Engineering, Quality, Healthcare