Design Quality Engineer II - Interventional Cardiology

Boston Scientific; Maple Grove (MN); Hybrid; USD 72,000 - 136,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific is seeking a Design Quality Engineer II for the Arbor Lakes campus in Maple Grove, MN. You will support design controls, risk management, and verification/validation across new capital equipment in Interventional Cardiology.

This hybrid role requires on-site presence at least three days per week and strong collaboration within a cross-functional team. You will maintain DHF and risk docs, apply problem-solving methods to quality issues, and ensure compliance with Quality

Qualifications

• Bachelor of Science degree in engineering or related field.
• 2+ years of experience in engineering within medical device or regulated industry.
• Knowledge of Quality System Requirements, Good Documentation Practices, ISO 13485, ISO 14971.

Responsibilities

• Develop, update, and maintain Design History File and design docs (Product/Component specs, prints).
• Develop and maintain risk management docs (Hazard Analysis, FMEAs).
• Execute Design Verification, Design Validation, and Usability protocols and reports.
• Collaborate in cross-functional teams to implement quality controls for product changes.
• Support PIRs, CAPAs, and NCEPs and resolve quality issues.

Skills

Quality system knowledge

Cross-functional teamwork

Independent work

Communication skills

Problem-solving

Education

Bachelor of Science in Engineering

Electrical/Computer/Biomedical Eng (preferred)

Tools

DFMEA

Hazard Analysis

Root Cause Analysis

Job description

Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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:Boston Scientific is currently recruiting for a Design Quality Engineer II at our Arbor Lakes campus in Maple Grove, MN. This is an exciting opportunity to participate as a design assurance team member in the development of capital equipment products for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.The Design Quality Engineer II will support the application of design controls and risk management to projects with a focus on new product development. This individual will work within a high performing cross-functional team to ensure safety, quality, and compliance of products.Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires being on-site at least three (3) days per week.Relocation assistance:Relocation assistance may be available for this position at this time.Visa sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:Develop, update, and maintain Design History File and Design Input / Output documentation (e.g., Product Specification, Component Specifications, and Prints)Develop, update, and maintain product Risk Management documentation (e.g., Hazard Analysis, Fault Tree, FMEAs)Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirementsWork within a cross-functional team to identify and implement effective controls and support new product and commercial design changes, specifically with regard to quality and risk managementApply sound, systematic problem-solving methodologies to resolve quality issuesProvide design quality support in the resolution of PIRs, CAPAs, and NCEPsApply basic problem-solving techniques to identify, communicate, and resolve quality issuesDemonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and proceduresWhat we're looking for in you:Required qualifications:Bachelor of Science degree in engineering or related field2+ years of experience in an engineering role within medical device or similar regulated industryKnowledge of Quality System Requirements, Good Documentation Practices, and relevant standards and regulations (e.g., ISO 13485, ISO 14971)Comfortable working independently and as part of a cross-functional teamCollaborative mindset and willingness to learn in a team-oriented environmentStrong written and verbal communication skillsPreferred qualifications:Bachelor’s degree in Electrical, Computer, or Biomedical EngineeringFamiliarity with quality tools and methodologies include DFMEA, Hazard Analysis, and Root Cause AnalysisDemonstrated ability to solve engineering problems using analysis, experimentation, and statisticsExperience with technical writing, such as specifications, test protocols, and technical reportsRequisition ID: 635253Minimum Salary: $ 71500Maximum Salary: $ 135800The 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.Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.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.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.