Senior Project Manager

ASP is looking for a Senior Project Manager who thrives on driving results and making an impact. In this role, reporting to the PMO Director, you will be accountable for leading multiple cross functional teams and driving execution across high visibility, complex projects with occasional oversight. You will lead critical medical device development projects across sterilization, washing and disinfection, and consumables translating innovative ideas into compliant, market ready solutions that protect patients and advance healthcare.

Location: Remote position in the US (preferred in PST, MST or CST) to support Irvine time zone

What Success Looks Like:

• Medium complexity projects delivered predictably through major development and commercialization milestones
• Cross functional teams aligned, risks surfaced early, and decisions made with clarity and speed
• Strong trust and credibility with functional and senior leaders

Duties and Responsibilities

• Lead Complex Medical Device Projects: Lead high impact medical device development projects across hardware, systems, and consumables from concept through commercialization, ensuring delivery against business, customer, and regulatory expectations.
• Drive Cross Functional Execution: Align and lead cross functional teams across Engineering, Quality, Regulatory, Operations, Marketing, and external partners to deliver integrated project outcomes on time and to standard.
• Strengthen Planning & Execution Rigor: Develop and continuously refine integrated project plans, proactively managing scope, schedule, resources, dependencies, and critical path to improve predictability and accelerate key milestones.
• Own Project Risk & Issue Management: Proactively identify, assess, and mitigate project risks, prioritizing actions based on business impact and ensuring timely escalation and resolution to protect delivery, quality, and compliance.
• Enable Effective Decision Making: Facilitate structured, data driven problem solving for complex technical and organizational challenges, enabling timely decisions and rapid course correction while preventing recurrence.
• Ensure Strategic & Regulatory Alignment: Own alignment of projects with evolving business priorities, customer needs, and applicable medical device regulatory and quality system requirements throughout the product lifecycle.
• Drive Stakeholder Alignment & Executive Communication: Own executive level communication, influence cross functional alignment, resolve trade offs, and maintain momentum across complex, multi team projects.
• Foster Collaboration & Continuous Improvement: Promote a collaborative, high performance environment that encourages innovation, continuous improvement, and shared accountability across project teams.

Qualifications

Education:

Bachelors degree in Engineering, Life Sciences, or a related technical discipline required.

Preferred Advanced degree (Masters Degree)

Years of Related Experience

• 3+ years of project management experience leading end-to-end product development and commercialization of regulated products.
• 2+ years in the Medical Device industry, including hands-on experience leading projects that resulted in FDA 510(k) clearance, with working knowledge of 21 CFR 820 and ISO 13485.
• Demonstrated ability to lead medium to large, global, and interdependent projects in technical domains, managing scope, risk, and stakeholder alignment.
• Hands-on experience with process improvement and metrics, including use of tools like Jira, Confluence, and Fortive Business Systems (FBS).
• Track record of mentoring and developing high-performing project teams, fostering innovation, accountability, and breakthrough thinking

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:

• Exceptional project and project management skills, with a proven ability to lead cross-functional teams through complex, high-impact initiatives.
• Agile leadership with familiarity with SAFe, and Lean practices.
• Excellent communication and stakeholder engagement, with the ability to influence and present effectively to senior executives and global teams.
• Strategic thinking and business acumen, aligning project goals with broader organizational objectives and market opportunities.
• Results-driven mindset, focused on delivering high-quality with measurable impact.
• Advanced problem-solving and decision-making skills, navigating ambiguity and driving clarity in fast-paced environments.
• High accountability and performance orientation, setting and raising standards, and holding teams to commitments.
• Inclusive leadership, fostering psychological safety, encouraging diverse perspectives, and promoting innovation.
• Metric-driven approach, leveraging KPIs and dashboards to track progress and drive continuous improvement.
• Experience using structured project management, planning, risk management, and continuous improvement tools; specific systems experience may include Microsoft Project, Jira, or equivalent platforms.
• Certification preferred: PMP, CAPM, or equivalent.

Responsibility for Others and Internal Interactions

• This role will report to the Director of PMO
• Potential internal interface activities that the position may encounter include:
• R&D Directors, Quality, Operations, Marketing, Regulatory Affairs, Service and Support on project planning/execution
• R&D managers and individual contributors
• Managers and individual contributors from cross-functional groups planning and executing projects

External Interactions

• Visit external partners, customer sites or market research facilities, occasionally
• Regular communication with development partners (e.g., product design companies)

Environmental, Health and Safety

All managers and employees shall proactively support ASPs Environmental, Health and Safety (EHS) Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality. It is the duty of every manager and employee to:

Ensure implementation of safety and environmental procedures, guidelines and standards.

Evaluate employee compliance and enforce established safety and environmental procedures and rules.

Create a safe work area environment, recognize safe activities, and reward good safety performance.

Provide training to employees when:

• Hired
• Transferred
• New substances, processes, procedures or equipment are introduced to the workplace and represent a new hazard

Measure safety performance and hold persons accountable for activities and results.

Ensure that incidents are investigated to determine root cause, and that corrective actions are taken.

Ensure employees wear required protective equipment.

Ensure EHS inspections are conducted monthly and corrective actions are implemented.