Sr. Project Manager

Overview: The purpose of the Sr. Project Manager (PM) role is to lead projects from initiation through to completion. The Sr. PM will ensure that projects are delivered on time, within budget, and according to scope. The Sr. PM will coordinate cross-functional teams to align efforts and remove obstacles, ensuring the project progresses as planned. The Sr. PM will serve as a central point of communication for all project stakeholders and New Product Committee (NPC) members to ensure a consistent flow of information between the internal teams. The Sr. PM will guide projects through the company's Stage-Gate process.

Responsibilities:

Project Planning and Execution:

• With input from cross-functional leaders, develop detailed project plans that support corporate strategic objectives. Plans to include project scope, timelines, budget, and resources
• Define and communicate clear project milestones, deliverables, and goals at relevant New Product Committee (NPC) meetings and Gate reviews
• Coordinate cross-functional teams (R&D, regulatory, commercial, manufacturing, quality, supply chain, clinical) to ensure alignment and efficiency

Timeline Risk Management

• Identify, assess, and mitigate risks that could impact the project timeline, quality, or compliance
• Develop, track, and adjust the project schedule to ensure timely product development and delivery and look for opportunities to accelerate
• Address any schedule delays or disruptions and make necessary adjustments to meet deadlines

Team Leadership and Communication

• Lead project team meetings, ensuring collaboration and clear communication among stakeholders
• Resolve conflicts, foster teamwork, and ensure that all team members understand their roles and responsibilities
• Regularly update senior management and other stakeholders on project progress, risks, and issues

Product Development and Design Control

• With input from the technical team, oversee the development timeline of the product, ensuring that all requirements (clinical, regulatory, quality) are met per SOPs
• Facilitate the documentation of design history files (DHF) in compliance with design control requirements
• Ensure that any changes to the product design are appropriately managed through change control procedures and NPC

Skills/Qualifications:

• BSME or MSME or equivalent with experience in a product development environment
• Minimum 8 years of related experience in the medical device and/or pharma industry
• Experience working and managing projects in a regulated environment while ensuring compliance with FDA and other international regulatory authorities
• Fluency with MS Project (or equivalent) and extensive experience managing projects and balancing resources through various phases of design control and/or in commercial production
• Proven track record of collaborating effectively with internal and external teams
• Strong familiarity with medical device risk management and design control procedures and understanding of regulatory requirements and guidance
• Project Management Certification is highly desired

For California, the base salary range for this position is $141,000-$231,000 (highly qualified) a year. The Company maintains highly competitive, performance-based compensation programs.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)