Principal Design Quality Assurance Engineer (604731)
Principal Design Quality Assurance Engineer (604731)
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Job Description
Additional Location(s): N/A
Diversity Innovation Caring Global Collaboration Winning Spirit High Performance
At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and highperforming employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll 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 crossfunctional 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 crossfunctional resources. Acts as division representative on crossdivisional projects defining the quality system(s).
- Leverages deep technical knowledge to lead teams through complex problemsolving initiatives. Applies systematic approaches (e.g. 5 Whys IsIs 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 problemsolving 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 bestinclass 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 were looking for in you:
Required Qualifications
- Bachelor of Science in Biomedical Engineering Mechanical Engineering or related degree.
- 8 years of medical deviceengineering experience.
- Indepth 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 1020%.
Preferred Qualifications
- 10 years of medical device engineering experience.
- Expertise in Usability and Human Factors engineering.
- Proficiency in Minitab Statistical Analysis software or equivalent.
- Six Sigma Black Belt Certification.
- Strong technical expertise in quality engineering principles design controls risk management and problemsolving methodologies.
- Excellent communication presentation and interpersonal skills with the ability to influence teams and leadership.
- Proven ability to lead and coach others driving a highperformance quality culture.
- Strategic mindset with handson execution balancing longterm 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 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 nonexempt (hourly) nonsales 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 nonsales roles may also include variable compensation i.e. annual bonus target and longterm 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) isnt just business its personal. And if youre a natural problemsolver 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 COVID19 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 COVID19 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 Companys policies or protocols change with regard to COVID19 vaccination.
Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safetysensitive positions. This role is deemed safetysensitive 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.
Required Experience:
Staff IC
Employment Type
Full Time
