Boston Scientific R&D Director Interventional Heart Failure 

United States, Minnesota, Maple Grove 

497150917

Responsibilities:

• Develop and lead an IHF team for early-stage development, ensuring a broad understanding of the field and a vision for a full portfolio.
• Mentor and guide R&D engineers in creating specific technological therapies.
• Collaborate with cross-functional teams to guide treatment technology development for targeted patient groups.
• Participate in cross-functional activities to advance early-stage projects into TDP/PDP phases.
• Form a team to create prototypes, testing methods, and early manufacturing processes, while defining user and product requirements.
• Organize VIP visits and foster innovation.
• Build partnerships with Exploratory, TDP, PDP and System Level projects.
• Contribute R&D insights for HFA/EFS setup and provide pre-submission input on standards, anatomical considerations, risk assessments, and testing for early clinical trials, aiming for pivotal trials and product launches.
• Ensure resource availability for Quality System compliance and adherence to the BSC Quality Policy.
• Promote a quality-driven work environment.
• Lead and develop teams to achieve organizational goals, encouraging diversity and full potential contribution.
• Oversee functional areas, managing activities, budgets, and ensuring policy and regulatory compliance.

Minimum Qualifications:

• 15+ years of experience in medical device industry
• Educational background in mechanical/biomedical engineering
• Clinical experience with interventional devices in cath labs
• Risk management proficiency in device development
• Regulatory knowledge including clinical studies and GCP
• Cardiovascular expertise in Structural Heart and heart failure
• Exceptional soft skills in communication, organization, and time management
• Technical proficiency with Solidworks, FEA, CFD, and related tools
• Verification skills in test method development
• FDA interaction experience with pre-sub discussions
• Leadership abilities to manage technical teams (10+ members)
• Adaptable development support for various project stages

Preferred Qualifications:

• Advanced knowledge in development, regulatory affairs, and quality assurance
• Proficiency in IHF/SHV procedures
• Specialization in Heart Failure, including related accessories and pharmaceuticals
• Comprehensive expertise in medical technologies for coronary artery disease treatment

Among other requirements, Boston Scientific maintains specific prohibited substance 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.

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.