R&D Project Manager- Medical Devices

Pyramid Consulting, Inc; Irvine (CA); Hybrid; USD 90,000 - 96,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid sick leave

Job summary

Pyramid Consulting, Inc. invites applications for an R&D Project Manager- Medical Devices on an Irvine, CA hybrid site.

This 12+ month contract role requires driving cross-functional NPD programs from concept through commercialization, with strong emphasis on quality systems and regulatory compliance. The ideal candidate will bring 5+ years of PM/Program Management in medical devices, hands-on experience with software, firmware and hardware development, and proficiency with Agile tools (Jira, MS

Qualifications

• 5+ years of Project/Program Management experience in New Product Development (NPD).
• Medical device industry experience with FDA regulations, ISO 13485, Design Controls, QMS.
• Experience managing complex product development involving software, firmware, hardware.
• PM methodologies/tools: Agile/Scrum, Jira, MS Project and/or Azure DevOps; PMP preferred.
• Strong leadership, stakeholder management, and cross-functional coordination.
• Direct experience managing NPD projects of increasing complexity.

Responsibilities

• Manage one or more large-scale projects/programs with strict Quality Systems and Change Control.
• Facilitate business case creation and resource prioritization across projects.
• Develop detailed program plans and manage changes accordingly.
• Implement QA, risk management, communications, staffing strategies; report status to stakeholders.
• Lead core team meetings; optimize processes, decisions, and workflows.
• Act as PM/Program SME; mentor peers and influence across teams.

Skills

Project management

Regulatory knowledge

Leadership

Stakeholder management

Agile/Scrum

MS Office

Education

Bachelor's degree in STEM

Master's degree preferred

Tools

Jira

Microsoft Project

Azure DevOps

Job description

R&D Project Manager- Medical Devices. 12+ Months contract opportunity with long-term potential and is located in Irvine California (Hybrid).

Job Diva ID: 26-24192

Pay Range: $65/hr - $70/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Manage one or more large-scale projects/programs, ensuring strict adherence to 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.

Key Requirements and Technology Experience:

• Must have;5+ years of Project/Program Management experience in New Product Development (NPD), leading cross-functional projects from concept through commercialization.
• Medical Device industry experience with a strong understanding of FDA regulations, ISO 13485, Design Controls, Quality Systems (QMS), and Change Control.
• Experience managing complex product development involving Software, Firmware, and Hardware (including thermoplastics/disposable medical devices).
• Proven expertise in project management methodologies and tools, including Agile/Scrum, Jira, Microsoft Project, and/or Azure DevOps, with PMP certification preferred.
• Strong leadership and stakeholder management skills
• A minimum of 5 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.
• 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.
• Bachelor's Degree in related field (STEM preferred).
• Master's Degree or equivalent - Preferred.

Our client is a leading Medical Deivces , and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.