Additional Location(s):US-MN-Maple Grove

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 Director of Clinical Engineering will function as the connection point between a cross-functional team responsible for coordinated efforts between R&D, Regulatory, Training, Therapy Development, Marketing, and customers. This role will be located in MN and able to travel, but it will primarily rely on a therapy development and FCE team to do the majority of travel. The focus will be on strategic alignment with the business on key initiatives to support development and commercial launch support for SHV (development and commercial) and IHF (development).

Responsibilities:

• Facilitate clinical-to-device interface.
• Organize and participate in clinical meetings to share best practices.
• Coordinate continued education meetings and training sessions, ensuring engineering competencies are met.
• Lead complex case planning initiatives.
• Conduct clinically relevant simulations.
• Arrange VIP and innovation visits.
• Contribute to root cause analysis through participation in OMS.
• Manage anatomical data for projects.
• Oversee EU and US testing in C-arm labs.
• Foster close partnerships with Exploratory, TDP, and PDP projects.
• Provide input for HFA/EFS setup from R&D.
• Offer pre-submission input.

Minimum Qualifications:

• 15+ years of relevant medical device experience
• Formal education in mechanical or biomedical engineering
• Cath lab experience with therapeutic interventional devices
• Proficiency in risk-based decision-making and development
• Familiarity with clinical studies, GCP, and regulatory guidelines
• Strong knowledge of cardiovascular science, including Structural Heart and heart failure
• Excellent communication, organization, and time management skills
• Experience with FDA pre-sub discussions
• Ability to manage teams of 10+ technical individuals
• Flexible approach to early-stage and long-term product development support

Preferred Qualifications:

• Profound expertise in development, regulatory affairs, and quality assurance, particularly in early-stage development
• Proficient in SHV and IHF procedures
• Skilled in performing TAVR, TMVR & TTVR, including mastery of associated accessories
• Extensive expertise in a broad spectrum of medical technologies essential for coronary artery disease treatment, encompassing vascular access, coronary imaging, preparation techniques, and utilization of interventional devices

Requisition ID:582808

Among other requirements, Boston Scientific maintains specific prohibited substancetesting 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 prohibited substance 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.