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Manager - Project Management (#20166)

Aisling Client Services Phoenix, AZ

  • Posted: over a month ago
  • Full-Time
Job Description

Manager - Project Management (#20166)

Position Summary:

The Manager- Project Management will be responsible for leading engineering projects for external suppliers and manage the site's Continuous Improvement goals. This person will be responsible for detailed project management, engineering validations, and collaborating with the Design Center for manufacturing engineering activities to support the continuity of business and capacity/capital improvement plans as they relate to external suppliers. They will develop and drive a project pipeline to increase efficiency, reduce cost and work within the constraints of budget, schedule and scope while managing risk and ensuring adherence to established processes and methodologies. Candidate will be responsible for identifying and executing against performance improvement opportunities and supporting successful implementations. This person acts as the critical technical Subject Matter Expert/liaison between Operations and the Design Center. They will also plan, organize, and coordinate the activities of direct reports and participate as an active member of the site's Leadership Team.

 Responsibilities include:

1. Support business activities for products manufactured at external suppliers including:

  • Develop long-term strategy and Continuous Improvement pipeline; provide technical and business support to the overall deployment of initiatives
  • Creation of plans and schedules for projects/CTW (Cost to Win) that may include purchasing and validating new equipment, process improvements and validations (IQ/OQ/PQ), supplier qualification/selection, and internal/external supplier audits
  • Identify opportunities for improvement in the areas that may include production transfers, material changes or improvements, and efficiency in material usage
  • Prepare the Capital Budget and maintaining control of expenditures
  • Support investigations and requirements of the QMS

2. Performance Management Responsibilities

  • Lead and coordinate activities that involve cross-functional teams (ex: External Suppliers, Purchasing, Quality, Engineering, R&D, Global Procurement)
  • Establish priorities and assign work to direct reports
  • Perform supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing, and hiring decisions and disciplinary actions
  • Provide updates to all levels of the organization
  • Develop and maintain budgets
  • Advise team to facilitate schedule achievement or resolve technical/operational problems in support of site goals
  • Review and approve documentation and checks for completeness and accuracy
  • Utilize DMAIC methodology to improve processes
  • Engage the talents of all associates towards the mindset of zero loss

3. Collaborate with Quality and R&D teams to successfully support all activities to transfer, maintain and commercialize products from design to manufacturing including participation in the following areas:

  • Develop and manage a transition plan and team
  • Lead and oversee Change Control Process for external suppliers
  • Process validation and method documentation
  • Manufacturing capacity planning
  • Component inventory transition plan
  • Facility selection, coordination & preparation
  • Coordination and validation of all new supplier tooling and molds
  • Equipment moves and installation
  • IQ, OQ, PQ protocol development and execution
  • Validation and training support
  • Design reviews and design for manufacturability
  • Evaluation and recommendation of new materials
  • Changes to product cost or process in conjunction with the design center
  • Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, EU MDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.
  • Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures for Environmental, Health, and Safety compliance.
  • Special projects and other duties, as assigned.

Required Qualifications:

  • Resourceful with an attitude to drive results and willing to think outside the box to stay on track to goal
  • Ability to develop solutions with business impact
  • Demonstrated proficiency in project management
  • Ability to analyze and optimize manufacturing and quality systems
  • Ability to create and provide training
  • Ability to Lead cross functional teams
  • Root cause analysis skills
  • Provide support, tools, and training to conduct meaningful project reviews
  • Ability to work under tight deadlines
  • Ability to effectively manage multiple projects and detail-oriented tasks
  • Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through completion on time and on budget
  • Financial acumen to effectively set and drive to a budget
  • Develop cost savings strategy and tactically execute
  • Strong organizational leadership with an ability to communicate clearly
  • Structured analytical and problem-solving techniques
  • Willing and able to learn from experience and enjoys complex problems and challenges associated with new experiences.

 Preferred Qualifications:

  • Experience in manufacturing based and/or PMA (Class-III) products a plus
  • MS or MBA degree preferred
  • PMP or related experience in Project Management
  • Experience leveraging a manufacturing management system to drive performance (ex: TPS)
  • Solid manufacturing experience in particular around process improvements
  • Understanding of GMPs and medical device regulations as they apply to manufacturing

 Education and/or Experience:

  • Bachelor of Science degree required in Bioengineering/Electrical/Mechanical/Chemical Engineering degree or related discipline
  • Minimum of (7) years relevant experience
  • Minimum of (2) years supervisory experience

Aisling Client Services


Phoenix, AZ



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