Job Description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, well give you the opportunity to harness all thats 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, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

About this role:

As part of the Peripheral Interventions electronic medical equipment R&D team you will be primarily responsible for design, development and maintenance of R&D systems. This position also involves helping senior management with planning, budgeting and strategy discussions as it relates to systems development and maintenance. This position will be the technical lead for new forward looking pipeline projects and innovation initiatives within the R&D team for various medical procedures spanning Boston Scientifics Peripheral Interventions Portfolio (e.g. cryoablation consoles, thrombectomy equipment, microwave generators, etc). You will be tasked with mentoring and empowering a strong team capable of delivering multi-project needs for the business.

Key Responsibilities:

* Develop and maintain adequate documentation for required regulatory approvals of the system. This includes but not limited to requirements, design documents, test plans and protocols, test reports, verification and validation reports, risk analysis, hazard analysis, and certification tests
* Responsible for modeling advanced system concepts and helping functional leads understand risks and possible mitigations for novel designs.
* Responsible for coordinating activities within R&D group and collecting input from functional leads to create system level plans and budgets.
* Help with vendor selection for production of new systems and interface with operations for design transfers.
* Help with IP management and interface with outside attorneys in patent creation and addressing issues with pending patents.
* Provide input into technology options and help with systems strategic planning activities.
* Hands on activity within the R&D team to support product development efforts.
* Lead technical efforts in innovation and early pipeline activities.
* Interface with physicians and develop requirements for products in coordination with marketing teams
* Mentors performance of individual systems team members as well as the electronic medical equipment cross functional team as whole.
* Identifies and addresses staff training and development needs.
* Works with the team to ensure sufficient processes and tools are in place to meet the requirements of the business
* Build strong technical leadership with a focus on electronic medical equipment and ablation
* Lead efforts in collecting voice of the customer to help define requirements for new products as well as lifecycle product improvements
* Work with cross-functional teams to provide systems engineering support for manufacturing and field service needs
* Ensure that all devices are developed and documented in accordance with internal SOPs (e.g. Design Control) and international standards such as ISO 13485, IEC 62304, and IEC 60601

Requirements:

* BS in biomedical engineering, mechanical engineering, computer science, electrical engineering or related discipline.
* Minimum 8+ years' experience in product development of electronic medical equipment and 4+ years as systems engineer
* Expertise in electrical, mechanical and software engineering with aptitude to identify and solve cross functional challenges.
* Expertise in medical device regulations and certification requirements for CE mark, IDE, 510(k) and PMA approval.
* Proficient in understanding the workings of electro mechanical systems
* Has technical knowledge and understanding of engineering design principals
* Understands and is able to adapt to the rigors of a regulated industry
* Ability to communicate effectively with cross functional team as well as customers and key project stakeholders
* Expert knowledge of requirements management tools
* Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
* Knowledge of the product development life cycle processes for capital systems
* Demonstrated ability to create and maintain system requirements and specifications

Requisition ID: 476704

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 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.