Project Manager

Job Description

PURPOSE OF THE POSITION

The Medical Device Design & Development Project Manager is responsible for the overall planning, coordination, execution, monitoring, and successful completion of assigned medical device development projects. This role ensures projects are delivered on time, within scope and budget, and in full compliance with company objectives, quality systems, and applicable regulatory requirements.

RESPONSIBILITIES

• Lead end-to-end planning and execution of medical device design and development projects.
• Define project scope, objectives, deliverables, and success criteria in collaboration with cross-functional stakeholders.
• Develop and maintain detailed project plans, schedules, and resource plans.
• Identify, allocate, and coordinate internal and external project resources.
• Manage project budgets, forecasts, and cost controls.
• Provide leadership, direction, and support to cross-functional project teams.
• Ensure project activities comply with internal quality procedures, design controls, and regulatory requirements (e.g., FDA, ISO, EU MDR).
• Monitor project progress and performance, identifying risks and implementing mitigation strategies.
• Manage project changes through formal change control processes.
• Communicate project status, risks, and milestones to management and key stakeholders.
• Conduct project evaluations, lessons learned, and post-project assessments to support continuous improvement.

SKILLS AND COMPETENCIES

• Proficiency with project management tools and software (e.g., MS Project, Smartsheet, Jira, or equivalent).
• Strong organizational, communication, and leadership skills.
• Experience in strategic planning, risk management, and change management.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Strong problem-solving and decision-making capabilities.

GENERAL OBJECTIVES

• Deliver projects on schedule and within approved budgets.
• Ensure effective cross-functional collaboration and stakeholder alignment.
• Proactively manage risks to minimize project delays and cost overruns.

QUALITY OBJECTIVES

• Ensure all projects are conducted in accordance with internal quality system procedures.
• Maintain compliance with applicable domestic and international regulatory requirements governing medical device development.
• Support design control, risk management, and documentation requirements throughout the project lifecycle.

EXPERIENCE REQUIRED

• Senior to mid-level experience managing projects in a regulated industry; medical device experience strongly preferred.
• Proven ability to lead cross-functional teams in a technical or engineering environment.
• Experience managing project schedules, budgets, risks, and change control processes.

EDUCATION & TRAINING PREFERRED

• Associate’s or Bachelor’s degree in Engineering, Life Sciences, Business, or a related discipline required.
• Project Management certification required or strongly preferred, such as:
• • Project Management Professional (PMP)
  • Certified Associate in Project Management (CAPM)
  • PRINCE2 (Foundation or Practitioner)
  • Agile or Scrum certification (CSM, PMI-ACP) is a plus
• Ongoing professional development in project management best practices is expected.

COMMENTS

Travel may be required.

Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and, most importantly, our unique company culture. At Endo-Therapeutics, we firmly believe that a diverse and inclusive environment fosters creativity, collaboration, and excellence, enabling us to deliver cutting-edge solutions to meet the evolving needs of the healthcare industry.
Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas.
In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals.
As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike.
We invite you to partner with Endo-Therapeutics, Inc. and experience firsthand our commitment to inclusiveness, innovation, and excellence. Together, we can drive advancements in medical device manufacturing, improve patient care, and make a positive impact on the healthcare industry.

Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and, most importantly, our unique company culture. At Endo-Therapeutics, we firmly believe that a diverse and inclusive environment fosters creativity, collaboration, and excellence, enabling us to deliver cutting-edge solutions to meet the evolving needs of the healthcare industry.\r \r Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas.\r \r In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals.\r \r As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike.\r \r We invite you to partner with Endo-Therapeutics, Inc. and experience firsthand our commitment to inclusiveness, innovation, and excellence. Together, we can drive advancements in medical device manufacturing, improve patient care, and make a positive impact on the healthcare industry.