Design Assurance Engineer I

Boston Scientific; Maple Grove (MN); On-site; USD 60,000 - 114,000; Full time

Job summary

Boston Scientific is seeking a Design Assurance Engineer I to join our on-site team in Minnesota. You will support medical device product development from concept to commercialization, focusing on risk management, test method development, and design verification planning/testing.

You will work with cross-functional teams to ensure safety, quality, and regulatory compliance, contributing to Design Controls, Risk Management, and Usability activities throughout the product lifecycle.

Qualifications

• Bachelor’s degree in Biomedical Engineering.
• Previous internship experience with Boston Scientific.
• Eligible to work in the U.S. without sponsorship now or in the future.
• 3 months experience in Design Quality Assurance at a medical device company.
• Strong communication and presentation skills; detail-oriented and organized.

Responsibilities

• Actively promote and participate in a cross-functional teamwork environment.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Provide quality and compliance input to project teams for project decisions and deliverables (Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Successfully complete engineering work in one or more of the following: test method validation, risk management, bench and verification testing.
• Support development and coordinate the execution of Design Validation and Verification activities.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
• Perform regulatory standard assessments and support regulatory submissions to notified bodies.
• Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

Skills

Design Quality Assurance

Test Method Validation

Risk Management

Usability Testing

Design Verification

Documentation

Cross-Functional Collaboration

Communication Skills

Education

Bachelor's degree in Biomedical Engineering

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.Design Assurance Engineer IWe will consider qualified applicants of all ages who are starting (or restarting) their careersAt Boston Scientific, we value collaboration and synergy. This role follows an on-site work model, requiring employees to be in our local office at least four days per week.Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this timeAbout the role:The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional team to ensure safety, quality and compliance throughout new product development. This position will focus on establishing robust risk management, test method development, and design verification planning/testing through the new product development processYour responsibilities will include:Actively promote and participate in a cross-functional teamwork environment.Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Successfully complete engineering work in one or more of the following: test method validation, risk management, bench and verification testing.Support development and coordinate the execution of Design Validation and Verification activities.Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Support the verification, validation, and usability testing to meet or exceed internal and external requirementsPerform regulatory standard assessments and support regulatory submissions to notified bodies.Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).Required Qualifications:Bachelor’s degree in Biomedical EngineeringPrevious internship experience with Boston ScientificMust be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization3 months experience in Design Quality Assurance at a medical device companyPreferred Qualifications:Focus on detailed work with emphasis on accuracy and completenessExcellent organizational and planning skills; drives for resultsStrong communication (oral and written) and presentation skillsDesign verification experienceRisk management for medical device (ISO 14971)Requisition ID: 634929Minimum Salary: $ 59900Maximum Salary: $ 113800The 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.