Medical Device Program Manager

Location: Irvine, CA
Department: Azzur of CA, LLC

Job Description

The successful candidate will have expertise in program and project management in the Medical
Device or related industry. The position will play a key role in supporting projects associated with
new and/or legacy products. This position will typically work cross-functionally, driving and
collaborating with representatives in R&D, Operations, Quality, Marketing, Clinical, and Regulatory to
assure the successful execution of business goals.


Key Responsibilities May Include:

• Program manager and technical leader for a team of cross-functional representatives in design,
development, and commercialization of Class I, II & III medical devices as well as related R&D or
business excellence programs.
• Develop both internal and external stakeholder relationships, expectations, and communications.
Present and facilitate discussions up to senior leadership level.
• Manage large scale to enterprise-wide projects within a program in accordance with established
project management methodologies.
• Drive the creation of project plans and critical paths, allocation of project teams, tasks, and
responsibilities. Manage project schedule, action items and communication plans.
• Develop appropriate milestone plans and manage program change to control scope, mitigate
risks, schedule and budget.
• Lead, manage and direct the development and execution of integrated project plans relevant to
the deliverables and ensure alignment across relevant functions and a smooth transition across
project phases.
• Build and maintain relationships with business representatives and stakeholders. Management of
KPIs of project delivery to ensure targets are met.
• Prepare project risk management plans and identify mitigations.
• Ensure external suppliers/partners are meeting expected timelines, delivery schedules and costs.
• Implement project improvement strategies to improve quality, reliability, and/or reduce cost.


Required Education & Experience:
• Bachelors degree with 7+ years of project and program management experience, preferably in
the Medical Device industry.
• Knowledgeable medical device standards such as ISO 13485 and CFR 830.30. Follow policies,
processes, and procedures in the quality system.
• Experienced in all facets of project management methodology including the generation and
maintenance of Gant Charts.
• Expert in MS Project or equivalent scheduling and tracking programs.
• Proven track record of successful collaboration and leadership to cross-functional teams to
advance complex projects to completion. Excellent organizational, leadership, teamwork, written
and verbal communication skills together with demonstrated ability to work in a highly matrixed
team environment with enthusiasm and a proactive, positive attitude.
• Proven problem-solving, analytical, and critical thinking skills.
• Experience with risk analysis methodologies and thorough understanding of data analytics.


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM.

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