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Senior Program Manager

Archimedic Inc

This is a Full-time position in Waltham, MA posted April 29, 2021.

About the Organization Building Tomorrow’s Medical Technology
– Helping innovators transform new medical technologies into real products that save and improve lives.
Archimedic provides full-service medical device product development, from concept through commercialization to corporate and academic clients.

We are a small group of hands-on engineers who work with our customers on complex design ideas, turning them into viable devices.

We are 100% focused on the medical device and MedTech industries, combining a passion for engineering with solid expertise to offer practical solutions in a wide range of clinical subspecialties.

Our projects range from telemedicine and diagnostic platforms to wearables, drug delivery devices, and surgical systems.

We offer a creative work environment with a highly collaborative team.

Number of Openings 1

Description
The Senior Program Manager role leads technical medical device programs while playing a role in product engineering.

This role reports to the Vice President, Program Management & Quality.

Essential Job Functions:
Program Management Activities:Ensures that projects are following Archimedic standardized program management process.

Ensures that key program objectives, timelines, and milestones are understood by internal and client team members.

Facilitates meetings to share progress, discuss issues, and ensure that key decisions are being made.

Client Communication & Satisfaction: Regularly communicates with clients to ensure consistency in expectations.

Proactively identifies gaps in expections and works with management to achieve alignment between Archimedic and Client team members.

Continuously strives for client satisfaction.

SOW Generation & Amendments: Participates in Discovery meetings and assembles draft Statements of Work (SOWs) to define project.

Collaborates with sales and engineering team members to collect feedback on SOWs.

Identifies scope changes as early as possible and drives project amendments to capture changes in budget, timelines, and deliverables.

Project Budget Compliance: Ensures that project is on track with project budgets.

Identifies progress-budget deviation early, communicates with management, and develops action plans to mitigate financial risks for clients and Archimedic.

Achieve Project Deliverables: Reviews project plans and ensures the team is focused on completion of key deliverables specified in SOWs.

Obtains written acknowledgement from clients when expectations of deliverables change.

Project Documentation: Documents project progress through minutes, presentations, and reports.

Ensures that photography, renderings, CAD screen shots, and other materials are captured at key project milestones.

Ensures that project documentation is accessible for future marketing, sales,and client needs.

Mentor: Provide mentoring and support to Program Managers.

Engineering Support: Contributes to engineering tasks as needed to achieve technical objectives.

Customer Focus: Provide professional, reliable, and prompt service to internal and external customers.

Work in partnership with others to meet and exceed customer expectations.

Interpret customers’ needs and take appropriate action.

Follow through on customer’s inquires in a professional and timely manner.

Travel: 10% travel is expected for this role.

Other duties as assigned.

Position Requirements
Required Education, Experience, and Specialized Knowledge and Skills:
Bacherlor’s Degree (B.S.) in Mechanical, Electrical, or Biomedical Engineering.

7+ years of proven experience and track record of creating new products in a medical device development organization.

5+ years of experience leading projects.

Experience with FDA, QSR, and ISO 13485 medical device regulations.

Experience with Risk Analysis tools consistent with ISO 14971.

Familiarity with US FDA regulations, i.e.

501(k), IDE, PMA.

Experience working in a consulting firm or similar service organization highly preferred.

Location Archimedic
– MA
Full-Time/Part-Time Full-Time

Pay Rate $110,000
– $130,000.

DOE

EOE Statement BeingYou@Archimedic
Archimedic is committed to creating a diverse environment and is proud to be an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, or disability.
Archimedic is committed to ensuring that a disabled employee has reasonable accommodations to successfully perform their role, while considering potential impacts to ongoing operations.

Team members in Archimedic’s Pennsylvania location must be able to use the stairs to move between offices floors (No elevator available).

Archimedic is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

This position is currently accepting applications.

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