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Sr. Program Manager

Job Details

Experienced
Redmond, WA
Full Time
4 Year Degree
$150,000.00 - $175,000.00 Salary/year
None
Day
Manufacturing

Description

EchoNous is a medical device company that is pioneering a new era in Point-of-Care Ultrasound. The EchoNous products combine superior image quality with handheld affordability and AI-enhanced efficiency. They are usable on iPads or Android tablets via USB-C connection and downloadable Apps, EchoNous products are designed and built in Redmond, WA. 

EchoNous is looking for the best and brightest minds to help us shape the future of healthcare and promote better patient care around the world. Joining our team means embracing a culture of innovation, collaboration, and endless opportunities for growth.

 

The Senior Program Manager position will lead EchoNous’s product development teams using industry best practices and a collaborative management style. The role requires solid knowledge and experience in device development (HW+SW) from early prototypes through production release. The senior PM will be responsible for managing the development and delivery of customer-centric products while adhering to various global medical device regulatory requirements.  In addition to leading programs, the role is also responsible for owning and improving EchoNous’s corporate product development process and mentoring team members and peers.

 

Responsibilities:

  • Provide overall corporate program management leadership, structure, and guidance.
    • Establish program requirements:  work with product management, R&D, Sales/Marketing, Operations, and other functional groups to define customer and business needs. Then work with engineering to translate these into product design requirements and specifications.
    • Detailed program planning:  collaborate with stakeholders (Product Management, Sales, Engineering, Operations, Service, etc.) to define the scope, budget, resources, and deliverables for each phase of the program.
  • Tracking and reporting: work with and lead cross-functional HW and SW teams to track schedules and deliverables with emphasis on phase-gate milestones. Negotiate trade-offs involving product features, risk, cost, and resources. Provide regular communications via dashboards or other tools and conduct formal program reviews with senior management, the program team, and other stakeholders. Eliminate barriers and escalate issues as appropriate.
  • Work with Product Management and the Change Review Board to prioritize and disposition technical issues and scope change requests.  
    • Work with the SW engineering team to monitor and synchronize related software development and testing.
  • Ensure compliance with global government regulations including FDA 510k, EU ISO-13485, UL, and others.
  • Co-own the corporate product roadmap with Product Management and participate in corporate strategy reviews and decisions.
  • Own and champion EchoNous’s product development processes.  Continuously seek innovative ways to improve development productivity with new technologies, systems, methods, and controls.
  • Work in an environment with global time zone needs. May require periodic attendance at evening or early morning meetings.

Qualifications

Qualifications:

  • 10+ years’ experience in medical device (HW+SW) or other regulated device industry. Knowledge of FDA & global medical device regulatory requirements is highly desirable.
  • 5+ years of program management experience in the medical device (HW+SW), aerospace, automotive or other highly regulated industry. Demonstrated success in managing complex programs within demanding timeframes.
  • Bachelor of Science degree in Engineering, Computer Science, or similar related degree.
  • Strong presentation, communication, negotiation, and team building skills.
  • Proven ability to lead teams, including an ability to motivate and hold others accountable.
  • Solid understanding of industry standard development processes and phases. Knowledgeable in standard practices for product requirements control, product configuration control, HW and SW development tools, NPI material planning and implementation.
  • Knowledgeable in medical device standards such as ISO13485 and FDA510k
  • Knowledgeable in software development/lifecycle processes.
  • The ability to work within a global environment. May require periodic attendance at evening or early morning meetings.

PREFERRED/Other:

  • PMI – PMP Certification.
  • HW supply chain knowledge (PCBAs, molded/machined parts, cables, other components)
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