Boston Scientific

Supplier Quality Engineer II - SFMD Neuromodulation

Boston Scientific • $71K — $135K *
Maple Grove, MN 55311In-Person
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS degree in engineering or technical field with min. 2 years relevant experience.
  • Experience in regulated industries (medical device, automotive, etc.).
  • Strong project management skills to influence cross-functional teams.
  • Knowledge in process validation, design controls, and CAPA.
  • Organized, self-driven, and effective communicator.
  • Ability to learn new software quickly (PLM, ERP).
  • Willingness to travel domestically and internationally (up to 25%).

Responsibilities

  • Evaluate and communicate quality issues to suppliers using systematic problem-solving.
  • Proactively assess supplier capabilities through on-site visits and discussions.
  • Plan and lead supplier audits for compliance with standards.
  • Manage quality issues related to supplier processes and design changes.
  • Conduct investigations on non-conformances at distribution centers.
  • Support investigations on supplier-related quality issues in the field.
  • Collaborate on project plans to hit milestones and manage contingencies.

Benefits

  • Collaborative work environment in a passionate global team.
  • Opportunities for professional development and cross-functional collaboration.
  • Commitment to patient safety and continuous process improvement.
  • Exposure to diverse medical device products through the Nalu acquisition.
  • Potential for travel to partner locations, enhancing professional experience.
Full Job Description
Recruiter: Spencer Gregory Hale

Supplier Quality Engineer II - SFMD Neuromodulation

About the role:
The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier's manufacturing processes. In this role, you will support SFMD products associated with the Nalu acquisition associated with the Neuromodulation division.

Your responsibilities include:

Sustaining Engineering:
  • Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
  • Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
  • Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
  • Manages sustaining quality issues, process change impacts, and design change implementations for the supplier, Nalu.
  • Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
  • Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
  • Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related.
  • Supports Supplier Change Impact Assessments for process changes at suppliers.
  • Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
  • Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.


New Product Development:
  • Execute SFMD Plan deliverables for launch of Nalu's products into BSC's Quality System.
  • Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
  • Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.


Quality System Champion:
  • Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
  • Identifies and advises management on potential improvements to quality systems and processes in the company.
  • Champions 100% compliance to company policies and SOP's.


What we're looking for in you:
Minimal Qualifications:
  • BS degree in engineering or technical field with minimum of 2 years of relevant experience.
  • Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
  • Experience in process validation, design controls, risk management, CAPA, SCAR.
  • Organized and self-driven.
  • Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
  • Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
  • Domestic and international travel up to 25%.


Preferred Qualifications:
  • 3+ years of medical device engineering experience preferred.
  • Medical Device Industry experience
  • Problem Solving and Project Management experience
  • Leadership experience on a materials or service commodity team.
  • Lead auditor of quality systems experience (ISO 13485 or similar).
  • ASQ certification (CQE, CBA, SSGB, SSBB) desired.


Requisition ID: 631099

Minimum Salary: $ 71500

Maximum Salary: $ 135800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

About Boston Scientific

BTG offers program solutions for small business programs, management workforce development, emerging business growth strategies, training development and delivery strategies, and business planning services.

Boston Scientific Careers

Joining Boston Scientific means becoming part of a global team dedicated to advancing science for life. With a focus on medical solutions that improve the health of patients around the world, Boston Scientific offers unparalleled job opportunities in the healthcare industry. Work You’ll Do At Boston Scientific, your work contributes directly to transforming lives through innovative medical solutions. As a member of our team, you will collaborate with skilled professionals to drive growth and innovation in healthcare. Our commitment to leadership in the industry makes Boston Scientific a place where careers flourish and professional development is taken seriously. Boston Scientific Leadership and Development Programs We are committed to nurturing a culture of growth and leadership. Boston Scientific’s development programs are designed to foster professional skills, leadership qualities, and a deep understanding of the medical devices industry. Whether you’re just starting out with an internship or you’re a seasoned professional, our programs help you achieve your career ambitions. Innovative Work Join a team where innovation is at the heart of everything we do. Boston Scientific is a leader in developing cutting-edge technologies and solutions that address unmet patient needs. By focusing on innovation, we maintain our leadership in the medical field and ensure continuous growth and improvement. Be Part of a Diverse and Inclusive Team At Boston Scientific, we believe that diversity fuels innovation. Our commitment to diversity and inclusion is evident in our hiring practices and the dynamic team culture we cultivate. Employees from various backgrounds bring unique perspectives that lead to better solutions and a more inclusive workplace. Benefits and Opportunities Boston Scientific is dedicated to providing employees with competitive benefits and a supportive environment that values health and well-being. Our benefits package includes comprehensive health coverage, retirement plans, and employee wellness programs, all designed to support your life both inside and outside of work. Explore Career Opportunities Whether you’re looking for an internship, a full-time position, or a leadership role, Boston Scientific offers a range of career paths. Explore job opportunities that match your skills and interests on our Careers page. We are always looking for curious, creative, and driven individuals to join our team. Stay Connected Keep up to date with the latest at Boston Scientific by following our Careers Blog. Gain insights from our team, learn about our culture, and get tips on everything from crafting your resume to acing your interview. Networking and Professional Growth Enhance your career through networking opportunities within Boston Scientific. Connect with leaders, gain industry insights, and build relationships that will help propel your career forward. Our professional environment encourages networking and collaboration, which are key to personal and professional growth. Join Our Team Search open positions at Boston Scientific that align with your skills and interests. We are looking for passionate, innovative, and solution-driven team players ready to make a difference. Start your journey with us today and be part of a company that’s dedicated to transforming lives through science. SEARCH BOSTON SCIENTIFIC JOBS Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at Boston Scientific.
Learn more about Boston Scientific
Size
41,000 employees
Market Cap
$66.3 billion
Industry
Healthcare
Net Income
-$82 million
Founded
1979
5 Year Trend
+7.2%
Revenue
$9.9 billion
NASDAQ
BSX
* Ladders Estimates

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