Medical Device - Sr. Project Engineer - Framingham, MA

As the Senior Project Engineer, you will lead project teams to ensure the successful design, development, and commercialization of medical devices and equipment software, while managing timelines, budgets, and regulatory compliance. You will also collaborate with cross-functional teams, coordinate external vendors, and maintain detailed documentation throughout the entire product lifecycle to meet company procedures and industry standards.

Client Details

My client leads the charge in cardiac medical innovation, developing a groundbreaking system that has already transformed treatment for patients worldwide. Their cutting-edge technology seamlessly integrates advanced platforms, offering new hope for those battling medical disorders.

Description

Responsibilities:

• Support research and development teams, consultants, and contract design/manufacturing companies in delivering medical devices and equipment software on time, within budget, and according to company procedures.
• Lead weekly project tactical meetings to ensure tasks are planned and coordinated effectively.
• Collaborate with project teams to create and maintain development plans from project conception through commercialization.
• Define project objectives, requirements, and assumptions in collaboration with the project team to structure projects or activities.
• Coordinate and track external development, testing, and production vendor timelines to ensure milestones are met.
• Work with Quality, Clinical, and Regulatory personnel to support regulatory submissions and ensure compliance with regulations.
• Ensure all design and development activities comply with regulatory requirements such as FDA, CE, and MDR standards.
• Maintain detailed, accurate documentation throughout the entire product lifecycle.

Profile

Ideal Candidate:

• 5+ years of experience as a PM or Project Engineer
• Excellent communication and team management skills, with the ability to drive cross-functional, global teams toward project goals.
• Strong ability to manage scope changes and perform impact assessments effectively.
• Highly organized with strong attention to detail, particularly in regulatory compliance documentation.
• Effective leadership, interpersonal, and communication skills to facilitate collaboration and team success.
• Ability to work well in a team environment, helping identify dependencies and resolve constraints.
• Ability to adapt quickly in a fast-paced, evolving company and work with a high sense of urgency.

Job Offer

What's To Offer:

• Competitive compensation with opportunities for financial growth.
• Extensive health and wellness benefits.
• Career development programs and mentorship.
• Creative and collaborative work environment.
• Access to cutting-edge technologies and continuous learning.
• Involvement in high-impact and innovative projects.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.