Engineering Project Manager

Job Summary:

We are seeking an experienced Engineering Project Manager to lead cross-functional team through product development life cycle for Class II medical device Engineering projects. Responsibilities include developing and maintaining detailed project schedules, facilitating design control activities, managing risk assessments, and coordinating with R&D, Quality, Regulatory, Clinical, Marketing, and Manufacturing teams.

The ideal candidate will have a strong background in design control, verification and validation, and be proficient in project management tools. Effective communication, leadership, and problem-solving skills are essential, as is the ability to manage multiple priorities in a fast-paced, highly regulated environment.

Duties & Responsibilities:

• Lead cross-functional project teams through all phases of product development, from concept to commercialization.
• Develop and maintain detailed project schedules, timelines, and resource plans using tools like Microsoft Project, Smartsheet, or Atlassian JIRA.
• Collaborate with departments such as R&D, Quality, Regulatory, Clinical, and Manufacturing to align project goals.
• Ensure compliance with regulatory standards including FDA 21 CFR 820, ISO 13485, and ISO 14971 throughout the project lifecycle.
• Facilitate design control activities, including design inputs/outputs, verification, validation, and design reviews.
• Drive project documentation and ensure accuracy, completeness, and consistency in accordance with quality management systems.
• Conduct regular project meetings, track action items, and communicate progress to stakeholders.
• Identify and mitigate project risks, escalating issues as needed to maintain timelines and budgets.
• Support process improvements related to project management, design control, and change control.
• Oversee document routing and approvals using PLM systems like Agile PLM.
• Ensure effective communication across all levels of the organization, including executive updates and technical presentations.

Minimum Qualifications:

• 5+ years' experience overseeing project management.
• Excellent conceptual, analytical, and problem-solving abilities.
• Expertise with product development methodologies and processes.
• Ability to excel in a fast-paced and dynamic work environment.
• Excellent verbal and written communication skills.

Preferred Qualifications:

• MBA or PMP certification preferred.
• Familiarity with regulated medical product development practices will be a plus.

Education:

• BS or MS degree in Engineering or a related field.

Compensation: The anticipated range for this position is $106,000 - $135,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

ABOUT US

For over thirty years, Masimo has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care. Today, Masimo delivers a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join our team, you'll be part of a culture that's driven by passion, challenging the status quo, and making an impact on the lives of others.