Katalyst CRO ยท 17 hours ago
Spec 3, R&D Project Mgmt
Irvine, CA
Contract
Onsite
Senior Level
6+ years expKatalyst CRO is a company focused on product development and commercialization in the medical device industry. They are seeking a Manager of Project/Program Management to lead project and program teams through various stages of product development, ensuring adherence to quality standards and effective communication with stakeholders.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Manage one or more large-scale projects/programs, ensuring strict adherence to Client's Quality Systems and Change Control Process
Facilitate the creation and approval of business cases within the program and coordinate the sharing and prioritization of resources among projects
Develop a detailed plan for the program and manage program changes accordingly
Implement program strategies related to quality assurance, risk management, communications, staffing, and other core areas. and communicate program status and data to maintain accurate and current program information for stakeholders
Facilitate core team meetings and other required meetings to support program execution; regularly assess and enhance meeting processes, decision-making, and workflows
Serve as a project and program management subject matter expert, including guiding and mentoring peers
Demonstrate high emotional intelligence; build trust, rapport, and respect with project team members and stakeholders; engage in honest and transparent conversations
Create a culture where teams can act with a high sense of urgency and accountability to meet/exceed individual and project goals
Understand complex problems and drive the team to effective resolution
Display perseverance and maintain appropriate forward momentum by keeping the core team engaged, even when faced with crises and/or changes
Demonstrate strong ability to influence downward, horizontally, and upward
Qualification
Required
Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field
A minimum of 6 years of direct experience managing New Product Development projects and/or programs of increasing complexity
Demonstrates a record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Thermoplastic Hardware and Disposable components
Proficient understanding of Medical Device Regulations and Product Development Process
Demonstrated record of leading within complex organizations require strong management skills
Proven expertise in the usage of MS Office Suite and related project management systems
Ability to see the 'big picture' and determine the course of action from an overall 'best for the business' perspective
Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to work cooperatively at all levels in a matrix environment to build and maintain the positive relationships required to accomplish organizational goals
Demonstrated proficiency in decision-making, with the capability to negotiate and balance priorities across multiple functional departments. Makes timely decisions in the face of risk and uncertainty
Preferred
Master's Degree or equivalent Preferred
PMP/Agile/Scrum Certification Plus
Experience in the medical device industry is highly preferred
Experience in the pharmaceutical, biotechnology, or healthcare sectors may be considered
Familiarity with Agile and Scrum methodologies, as well as project management software such as Jira and Microsoft DevOps
Meticulous attention to detail
Ability to lead meetings with external representatives
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase