Medical Device Program Manager

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

Job Description

About Azzur:

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.


Do What You Love

At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals.  We take crucial steps to ensure that each employee is fulfilled both in and out of the office.

In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 4 core values; Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun. 

It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.

We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.

If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.

Ideal Qualities:

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others. 
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing growth. 
  • Ensures activities are efficient, optimized, and client-centric. 
  • Highly motivated and organized, solutions oriented leader
  • Curious and adaptable - has the ability to transform knowledge into actionable activities
  • Able to produce results in a fast paced, collaborative environment   

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project.  The level of knowledge expected will be commensurate with level of incoming experience.

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.

  • 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
    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.

Qualifications

  • 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.

Perks of Working at Azzur 

  • Medical, Dental and Vision
  • Competitive 401K plan
  • Volunteer Paid Time Off
  • Flexible Paid Vacation Time
  • Employee Recognition Program
  • Diversity and Inclusion Initiatives
  • Training and Mentorship Opportunities

Find us on social media 

Instagram: Azzur_LA

View our culture video in Youtube: https://www.youtube.com/watch?v=9VmKkBLkoFQ



Apply Now

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