Principal Design Quality Assurance Engineer

Boston Scientific Gruppe; Marlborough (MA); Hybrid; USD 103,000 - 197,000; Full time

Job summary

Ein etabliertes Unternehmen im Gesundheitswesen sucht einen Principal Design Quality Assurance Engineer, der eine Schlüsselrolle in der Qualitätssicherung spielt. Diese spannende Position erfordert umfassende Erfahrung im Qualitätsingenieurwesen und regulatorischen Anforderungen für die Medizintechnik. Sie werden die Verantwortung für die Einhaltung von Vorschriften und die Förderung von Best Practices übernehmen, während Sie in einem dynamischen Team arbeiten. Diese Rolle bietet die Möglichkeit, an innovativen Projekten zu arbeiten, die das Leben der Patienten verbessern. Wenn Sie eine Leidenschaft für Qualität und Sicherheit haben, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• 8+ Jahre Erfahrung in der Medizintechnik erforderlich.
• In-depth Kenntnisse der US-amerikanischen und internationalen Anforderungen.

Responsibilities

• Leitet die Umsetzung von Qualitätsanforderungen in Projekten.
• Mentor für Ingenieure zur Förderung einer Kultur der Zusammenarbeit.

Skills

Qualitätsingenieurwesen

Regulatorische Anforderungen

Usability Engineering

Problem-Lösungs-Techniken

Kommunikationsfähigkeiten

Education

Bachelor in Biomedizintechnik

Bachelor in Maschinenbau

Tools

Minitab

Job description

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Principal Design Quality Assurance Engineer

Onsite Location(s):

Marlborough, MA, US, 01752

Additional Location(s): N/A

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 this role:
The Principal Design Quality Assurance Engineer is a seasoned professional with experience in quality engineering and regulatory requirements for the medical device industry. This role serves as a driving force in the quality department, championing excellence, compliance, and continuous improvement across projects and teams. The position is part of the design site for the Endoscopy Division and supports activities such as New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.

This is a hybrid position based out of Marlborough, MA with a minimum of three days per week onsite.

Your responsibilities include:

• Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices.
• Leads the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans. Leads the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Guides the successful completion of major programs and may function in a project leadership role.
• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Acts as division representative on cross-divisional projects defining the quality system(s).
• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
• Guides and mentors engineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
• Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders. Uses influence and negotiation skills to integrate quality perspectives into business decisions.
• Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.
• Supports internal and external regulatory audits as audit facing subject matter expert as required. Supports regulatory responses through technical writing and submission consultation as required.

What we’re looking for in you:
Required Qualifications

• Bachelor of Science in Biomedical Engineering, Mechanical Engineering or related degree.
• 8+ years of medical deviceengineering experience.
• In-depth 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

• 10+ years of medical device engineering experience.
• Expertise in Usability and Human Factors engineering.
• Proficiency in Minitab Statistical Analysis software or equivalent.
• Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence teams and leadership.
• Proven ability to lead and coach others, driving a high-performance quality culture.
• Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.
  

Requisition ID:604731

Minimum Salary:$103700

Maximum Salary: $197000

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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

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 identify, 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, Six Sigma Black Belt, Six Sigma, Medical Device Engineer, Testing, Engineering, Management, Technology