Intuitive Surgical Careers

Senior Project Manager – Compliance Programs

US-CA-Sunnyvale, California
Engineering


Job Description

Job: Engineering
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 182868

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

Joining Intuitive Surgical means joining a team dedicated to using

technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary function of position:

The Senior Project Manager – Compliance Programs will be responsible for leading deeply cross-functional teams, identifying activities, monitoring progress, and ensuring timely project delivery for various compliance programs including the new European Union Medical Device Regulation (MDR).

Job Description: 


• Lead a cross functional project team in the creation of project deliverables, realistic project timelines, and project budget.
• Deeply understand current Medical Device Directives (MDD) requirements, guidance, and application of the regulation
• Work with regulatory intelligence and quality systems staff to assess new compliance regulations’ impact on the business processes.
• Engage with executive management to communicate status, resource needs, and risks
• Work with process architects, subject matter experts, and team members to identify sustainable processes based on regulation requirements
• Utilize a broad understanding of Quality Management Systems (QMS) elements and impact within Medical Device organizations (Post Market, Risk, Clinical, Regulatory Affairs, Labeling, Reprocessing, etc.)
• Identify project risks, develop mitigation strategies, and monitor project health.
• Utilize project management tools and templates (project plans and trackers) to support lessons learned helping drive consistency across projects.
• Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization.

Qualifications

Skill/Job Requirements:

• A Bachelor’s Degree or related equivalent work experience required
• A minimum of 7 years of experience in program or project management preferably within a regulated industry such as medical devices, healthcare, pharmaceuticals, or aerospace / defense required
• Demonstrated track record of team leadership, building teams, and relationship management required
• Strong communication and presentation skills required
• Ability to define projects and their goals, estimating budgets, risks and resources required
• Understanding of the EU Medical Device Regulation (MDR) and exposure of implementation strongly preferred
• Experience communicating with regulatory authorities and notified bodies strongly preferred
• Exposure to industry groups (AdvaMed, Med Tech Europe, etc.) to leverage materials, collaboration, and industry peer collaboration preferred
• Experience with IT implementations to support regulation requirements preferred
• Experience with MS Project, Microsoft Excel, Word, PowerPoint and/or other standardized project management tools/documentation preferred
• Certification in Project Management preferred (PMP or Masters Certificate in Project Management), LEAN certification is preferred
• Ability and willingness to travel both domestically and internationally up to 25% of the time


We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.