Senior Technical Project Manager

Full Spectrum Software, Inc.; Westborough (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Full Spectrum Software, Inc. is seeking a Senior Technical Project Manager to oversee product development projects within medical devices, life sciences, and robotics. The role requires strong leadership skills, technical background, and a proven track record in project management, particularly in regulated environments. Candidates should excel in communication, negotiation, and maintaining client relationships, while ensuring compliance with industry standards.

Qualifications

• 10+ years in managing full product development.
• Experience with medical device technologies (FDA Class 2/3).
• Working knowledge of FDA regulations and quality systems.

Responsibilities

• Lead execution of multiple projects with clear communication.
• Manage client relationships and conduct project reviews.
• Ensure compliance with FDA and project management best practices.

Skills

Communication

Leadership

Negotiation

Project Management

Job description

Technology has never been more present in our lives than today. Everything from connected medical devices to robotics to mobile apps are becoming more a part of daily life. A career at Full Spectrum will allow you to be at the cutting edge of engineering driven innovation. If it excites you to develop new products and learn new technologies on a regular basis from a diverse set of customers, then this is the place for you.

We have a passionate team of experienced professionals who have first-hand experience developing products. Our clients are dependent on us to bring their next innovative product to market. Come help us build the future, come join Full Spectrum!

We are seeking an experienced Senior Technical Project Manager (TPM) to lead and oversee complex product development projects within our specialized domains. The ideal candidate will have a strong technical background, consulting experience, exceptional leadership skills, and a proven track record of managing projects in regulated environments.

The Senior TPM is responsible and accountable for leading fast-paced software/hardware programs with clients in the medical device, life sciences, robotics, and other industries. This is a client-facing role whereby the Senior TPM will manage and nurture client relationships.

Roles and Responsibilities

Project Management:

Manage day-to-day execution of multiple projects/workstreams and supporting strategies using standard project management tools and practices. Lead cross-functional teams to deliver high-quality solutions on time and within budget. Maintain clear and consistent communication with both internal and client stakeholders, providing regular project updates and status reports.

Createproject plans and schedules and provide budgetary input for new development projects. Develop clear and attainable project objectives, build project requirements, and manage the constraints for projects (cost, time, and scope). Maintain and track project team performance to targets and metrics.Provide accurate and timely reporting on resource utilization, spending and budgets, schedule and deliverable status, and project risks, etc. Plan resource requirements and negotiate team resource assignments with functional managers within a matrixed engineering organization. Manage sub-contract and partner resources. Track progress to requirements and plan; resolve deviations and mitigate project risks.

Client Relationship:

Conduct successful project, programmatic, and design reviews; inform stakeholders and leadership of unanticipated or potential issues/concerns as soon as they are known, proposing solutions and trade-offs to achieve successful project outcomes.

Participate in and contribute to development of project scope, approaches, plans and estimates.

Provide accurate and timely project reporting.

Leadership:

Manage and drive compliance to FDA, regulatory and standards requirements. Manage and drive compliance to PMO best practices and QMS policy and procedures. Contribute to continuous improvement in project management best practices and processes. Lead project scope and estimate development in collaboration with engineering and account management resources.Motivate and organize project execution teams; negotiate and resolve personal/team conflicts and project/functional conflictsDrive successful execution and achievement of project and business goals.Lead the creation of project plans, including budget and resource planning, to develop and commercialize innovative and complex products and systems employing software, hardware, robotics, and other technologies.

Previous Experience:

10+ years of successful experience in managing and leading full product development lifecycle projects.Experience with complex medical device technologies (FDA Class 2/ 3 highly desired), IVD, life science instrumentation, or robotics is preferred. Track record of leading multi-disciplinary engineering and technical teams, hardware/software integration is preferred knowledge of Waterfall and Agile development; strong understanding of the application of Agile development methodologies to regulated product development preferred.

Must be a skilled and determined communicator and negotiator.

Ability to manage multiple projects/workstreams simultaneously.

Must have strong leadership skills and be very collaborative and relationship oriented.Working knowledge of FDA regulations, quality systems and regulatory standards (e.g. IEC 62304, ISO14971, ISO 13485).

Excellent verbal and writing skills as well as presentation expertise to senior level leadership.

Experience using standard project management tools, software, and methods. Strong Motivational fit.

Travel: Ability to travel (locally)10-20% of the time.

Full Spectrumis a leading provider of softwareand systemdevelopment and testing services. We boast analmost 40-year history in successfully designing and developing over1,000Class I, II, and III medical device and non-medical solutions. As one of the earliest ISO 13485 certified software providers in the domain, Full Spectrum has a proven track record of helping our customers translate their business objectives into successful commercial products.