Design Assurance Quality Engineer III

Boston Scientific; Marlborough (MA); Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific seeks a Design Assurance Engineer to support medical devices through operations, development and sustaining activities. You will implement quality-engineering methodologies meeting regulatory requirements and act as a quality representative across projects.

The role follows a hybrid work model with in-office collaboration at least three days per week, and requires knowledge of US and international medical device regulations, design controls, risk management and process

Qualifications

• Strong understanding of US and international medical device requirements including 21 CFR part 820, MDD/EU MDR, EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.
• Experience in medical device engineering and quality assurance practices.
• Ability to apply design controls and quality methodologies in projects.

Responsibilities

• Provide quality and compliance input for post market product sustaining activities including design changes and supplier surveillance.
• Apply systematic problem-solving methodologies (e.g., 5 Whys, DMAIC) to quality issues.
• Provide quality input to project teams on design controls, design reviews, and verification/validation activities.
• Champion compliance with company policies, SOPs and work instructions.
• Support quality metrics and data analysis for manufacturing and assembly improvements.
• Assist internal and external regulatory audits as required.
• Analyze quality data and risk management linkage for management reviews.

Skills

Quality engineering

Regulatory knowledge

Problem solving

Communication

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related degree

Job description

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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:

The Design Assurance Engineer directly supports medical devices through operations, product development and sustaining functions. Develop, establish, and maintain quality-engineering methodologies, system, and practice 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. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.

Work Mode:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation Assistance:

Relocation assistance is not 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.

Y our responsibilities will include:

• 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 PIRs, Field Signals Evaluations and Field Actions.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Champion compliance to company policies, work instructions and SOPs.
• Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
• Support internal and external regulatory audits as required.
• Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Understand and support linkage of field data and Risk Management

Required Qualifications

• Minimum of a Bachelors degree in Biomedical Engineering, Mechanical Engineering or related degree.
• Minimum of 3 years of medical deviceengineering experience.
• Detailed understanding and working knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Preferred Qualifications:

• Strong communication (oral and written) and presentation skills.
• Ability to collaborate and work on Global team
• Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies (Six Sigma / CQE certification preferred).

Requisition ID:636304

Minimum Salary:$82100

Maximum Salary: $156000

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.

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 byprovidinga 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,neurologicaland 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 specificprohibited substancetest 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.

Nearest Major Market: Boston

Job Segment: Biomedical Engineering, Medical Device Engineer, Compliance, Quality Engineer, Medical Device, Engineering, Legal, Healthcare