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 Sr Design Assurance Engineer will have the opportunity to work for a worldwide and diverse company who puts patients first. The Sr Design Assurance Engineer will develop, establish and maintain quality engineering methodologies, systems, and practices which meet Boston Scientific (BSC), customer, and regulatory requirements. He/she/they will serve as a quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. He/she/they is responsible for assuring all requirements are met for the Product Development Process (PDP), Risk Management, Design Controls, Usability Testing, and External Manufacturer Production Controls within technical development concepts, new product development, post market product sustaining, or system/services support. He/she/they will work in fast paced Cross-Functional Team to develop and support New Product Development or sustaining activities, helping to ensure development of safe and effective new products.
Your responsibilities will include:
- Support the design, development, verification and validation of finished devices and accessories used in Boston Scientific Endoscopy product lines during their entire Development Life Cycle, from the Requirements gathering phase to the End-of-Life phase.
- Design Controls: Work on cross-functional teams providing quality and compliance input for project decisions and deliverables (e.g. Design & Development Plan, User Needs, Design Requirements, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure compliance to the laws and regulations of the targeted market for distribution.
- Execute Quality Deliverables: Creation and review of Quality Deliverables to support products including but not limited to:
- Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA) to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
- Lead product usability and design validation efforts for new product development and design change projects.
- Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
- Creative and resourceful problem-solving skills for moderate to complex mechanical and electrical devices
- Audit Support: Support internal and external regulatory audits.
- Product Support: Provide key quality trending information and data for Management Review and Complaint Reviews. Provide quality and compliance input and coaching for product development and/or 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, PIR’s and Field Actions. Lead CAPA efforts, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
- Quality System Champion: Advise management on potential improvements or enhancement to quality systems and processes in the company. Support development, implementation and training of corporate quality initiatives.
Required Qualifications:
- Minimum of a Bachelors Degree in Mechanical or Biomedical Engineering or related field
- Minimum of 5 years of Medical device engineering experience
- Understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Regulation, EN ISO 13485, EN ISO 14971, and EN ISO 62366.
- Familiarity with the US and International regulations including 21 CFR part 820, EN ISO 13485, EN ISO 14971, EN ISO 62466, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
- Travel 10-15%
Preferred Qualifications:
- Masters degree preferred.
- Strong communication and presentation skills.
- Ability to collaborate and work on a global team.
- Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
“Among other requirements, Boston Scientific maintains specific drug testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing requirement is to increase workplace safety in compliance with applicable law.”
Requisition ID: 564950
Among other requirements, Boston Scientific maintains specific drug testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
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 is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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.