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Sr. Project Manager-Manufacturing at Tandem Diabetes Care

Posted in Information Technology 14 days ago.

This job brought to you by eQuest

Type: Full-Time
Location: San Diego, California





Job Description:

What you’ll be doing:


The Sr. Project Manager manages the design and commercialization aspects of key new products with responsibility for driving collaboration of cross-functional product commercial teams. Acts as the internal liaison between engineering, marketing, manufacturing, RA/QA and sales management for the purpose of scheduling projects, driving the timely launch of projects, budgeting resources, and reporting on the progress of several projects that are simultaneously being prepared for commercialization. Acts as a key facilitator in Tandem Product Commercialization Process (PCP) including facilitation of corporate Phase Review Discipline meetings and progress tracking with the Tandem Product Steering Committee (PSC). The Sr. Project Manager is also expected to lead or participate in product development continuous improvement projects led by the PMO.


We are looking for an experienced project management candidate to join the Tandem team. This candidate will be focused on operations projects where they will be driving projects that help enhance and scale our manufacturing output for sustaining and new pipeline products to support the ever growing patient need of our insulin pumps worldwide. The candidate will have worked in a previous role where they interacted with medical device manufacturing teams and helped drive manufacturing and/or automation projects to increase throughput and product yields. Engineering background is preferred with 5+ years experience as a project manager in an FDA regulated environment. Candidate should be able to travel both domestically and abroad and will need a valid passport. Travel will be dependent upon project phase and can be as much as 50%. Must have ability to drive cross-functional teams in a high paced environment under pressure to meet project timelines with capability to handle adversity. Candidate to show experience in presenting to executive management. Ability to problem solve and pull and disseminate information from the team to communicate effectively to project stakeholders. Experience in risk identification/management with understanding on how and when to escalate issues that derail project progress.


Who we are:


Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation.  “In Tandem” means together, and we strive to embody that in every aspect of our business.  We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.


We’ve have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.


Read more about our company & culture here: https://www.tandemdiabetes.com/careers/life-at-tandem and see what our customers are saying here: #tsliminthewild


 


What you need for this position:


PRIMARY DUTIES & RESPONSIBILITIES:




  • Provides project management expertise and leadership to a multi-functional core team from Concept through Commercialization following Tandem’s standard process for product development and/or Design change; ensures implementation and compliance to Design Control procedures and improvements of systems, procedures and documentation when appropriate

  • Plans and directs all aspects of software/systems projects. Establishes project plans and objectives, develops project cost analysis, establishes and manages the project schedule and budget, manages resources, tracks progress and provides updates to management. Works closely with the Product Management, Program Managers, and functional heads to resolve resource allocation issues, conflicts, and priorities and to ensure projects are staffed appropriately, completed on time, and within budget constraints. Ensures efficient transfer of product from R&D to manufacturing and external marketing.

  • Leads/participates in process improvement initiatives related to product development, resource management and allocation, design controls, and other areas that impact cycle time, efficiencies, and compliance in medical device product development

  • Communicates and presents regular and timely project status updates to various levels of the organization including the executive management team.

  • Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

  • Other responsibilities as assigned.

REQUIRED QUALIFICATIONS:




  1. Knowledge, skills & abilities:

  • Ability to work in matrixed environment, establishing a sphere of influence with both the functional and vertical organizations.

  • Ability to drive cultural change through implementation of best practices in project teams.

  • Ability to communicate and influence up in order to manage project scope and resources.

  • Ability to keep project teams focused, motivated, creatively work to keep the projects on schedule.

  • Proficient in the use of Project Management Tools for planning, work breakdown, scheduling, task estimation, and collaboration.

  • Advanced Microsoft Office skills:

  • Excel:  Forms, Formulas, Functions, Pivot Tables, & Graphs

  • PowerPoint:  Graphics & Animation

  • MS-Project:  Resource loading, tracking

  • ECO writing/review

  • Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.

  • Ability to interact with executive management on a regular basis.

  • Ability to represent Tandem at professional and business functions in a competent manner.

  • Excellent advocacy and persuasive skills.

  • Ability to maintain confidentiality.

  • Ability to organize and prioritize workflow and to meet established timeframes.

  • Ability to work under pressure.

  • Ability to maintain updated knowledge of products, procedures and of changes within the medical device industry.

  • Ability to provide feedback and suggestions for improvement on the Product Development Process.

  • Ability to assess a problem quickly and determine to what level it should be elevated, directing staff/customers to the correct person(s).


  1. Minimum experience:

  • 6 years’ experience managing projects in FDA-regulated and ISO 14971 certified industry.

  • 3 years’ experience in the medical device industry and compliance to internal Quality Systems.

  • Experience in managing projects from inception to post-market sustaining using a phase-gate methodology.

  • Knowledge and experience in the implementation of regulatory requirements for medical device development such as FDA’s Design Controls, ISO’s Risk Management and Medical Device standards, ISO Software Development standards (e.g. IEC 62304).

  • Knowledge of agile/scrum development methodology.

  • Strong understanding of engineering principles, theories and concepts.

  • Certificate in Project Management, preferred.

  • Scrum Certification a plus.

 




  1. Minimum certifications/educational level:

  • Requires a bachelor’s degree in Engineering or equivalent training.

  • Certificate in Project Management (PMP) and/or Portfolio Management (PPMC) preferred.

 


JOB SCOPE:



  • A seasoned, experienced professional with a full understanding of area of specialization.

  • Resolves a wide range of issues in creative ways, demonstrating good judgment in selecting methods and techniques for obtaining solutions.

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

  • Normally receives little instruction on day-to-day work, general instruction on new assignments.

What’s in it for you?


 


We’ve got you covered.  We offer a robust benefits package to support your health and your family.  From medical, dental, and vision, to flexible spending accounts for both health and dependent care – Tandem’s got you covered!


Stay well with us.  Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.


Invest in your career.  Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.


Live your life.  Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan.  Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.


Celebrate in Tandem.  Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick’s Day, costume-contest for Halloween, and the annual JDRF walk.


 


If you are applying for this job and live in California, please read Tandem’s CCPA Notice:


https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants





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