Project Manager - Medical Device

Suntra MedTech Solutions; Bedford (NH); Hybrid; USD 100,000 - 120,000; Full time

Job summary

A prominent MedTech company is seeking a Program Manager to lead teams developing innovative medical products. The successful candidate will manage project activities, ensuring deliverables meet requirements and timelines. Responsibilities include leading cross-functional teams of software and hardware engineers, interacting with clients, and navigating regulations. Exceptional organizational skills and 5-10 years of project management experience in a medical device environment are key. This role offers a hybrid work schedule, with onsite presence required 3-4 days a week.

Qualifications

• 5-10 years of software development project management experience in a medical device environment.
• Strong knowledge of current technologies, tools, automation, and processes.
• Working knowledge of FDA regulations and international standards related to medical devices.

Responsibilities

• Manage all activities of the project team, including schedules and budgets.
• Lead teams of software engineers coding in various languages and environments.
• Identify project risks and be primary contact for customer communications.

Skills

Agile management

Project management

Software development

Interpersonal communication

Organizational skills

AI tools proficiency

Knowledge of FDA regulations

Education

BS in engineering

Tools

C/C++

C#

Qt

Python

Job description

We are seeking a Program Manager with a background in software and hardware development to lead teams developing software and electromechanical systems for medical products. Our programs can include combinations of embedded, desktop, web, mobile, and cloud software as well as complex electromechanical devices. We will look for your experience implementing and leading software/firmware/hardware projects from concept to production. You will stand out with a background developing software/firmware for medical devices.

At Sunrise you will:

• Manage all activities of the project team, ensuring that all contract deliverables and product/project requirements are being fulfilled, including schedules and budgets
• Lead teams of highly skilled software engineers coding in a range of programming languages and environments, including C/C++, C#, Qt, Python, and more
• Lead teams of engineers developing electrical and mechanical solutions to complex problems
• Be the lifeline to our clients, responsible for understanding their needs, technical requirements, and schedule; generating project plans and documentation that include accurate requirements and scope definitions. You will identify project risks and mitigations, and be the primary point of contact for customer communications

We will look for:

• Exceptional planning and organizational skills, with the ability to manage multiple projects concurrently, and a deep understanding of Agile-based software development
• Strong knowledge of current technologies, tools, automation, and processes
• Aptitude for leveraging AI tools (Cursor AI, CoPilot, etc.) for software and product development
• Working knowledge of FDA regulations and international standards related to the medical device industry including design controls for FDA Class II/III products
• Strong presentation, interpersonal, communication, follow-through, and organizational skills
• 5-10 years of software development project management experience in a medical device environment
• BS in engineering with software/firmware background
• Hybrid work environment, onsite 3-4 days a week

You will stand out with:

• Familiarity with embedded, mobile, cloud, and client-server architecture and database development
• Direct engineering experience developing hardware or software
• Experience in an engineering services environment