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:

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required.

Preferred Advanced degree (Master’s 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