Jobs at KP Recruiting Group

View all jobs

SR. PROJECT MANAGER-MEDICAL DEVICE MANUFACTURING

SAN JOSE, CA
The Senior Program Manager is accountable for leveraging new and diverse approaches resulting in optimized solutions by leading the team through technical, quality, regulatory, manufacturing, and commercial problem solving and decision making, ensuring that the functional experts are held accountable.

The Senior Program Manager will be expected to have a deep understanding of Project Management methodologies, Root Cause Analysis, Value Stream Mapping and Continuous Improvement principles. He or she will drive for continuous improvement and agility in the sustaining process ensuring that project timelines are consistently met.

Senior Manager, Project/Program management Sustaining Engineering

 

Leading multi-functional Sustaining Core team(s) and Project team(s) within a matrix and, FDA and ISO compliant organization, the Senior Program Manager is responsible for managing multiple sustaining engineering projects which heavily interfaces with R&D to execute. The Senior Program Manager will manage a high volume of projects by implementing a structured sustaining process and ensures timely completion.

 

The Senior Program Manager is accountable for leveraging new and diverse approaches resulting in optimized solutions by leading the team through technical, quality, regulatory, manufacturing, and commercial problem solving and decision making, ensuring that the functional experts are held accountable.

 

The Senior Program Manager will be expected to have a deep understanding of Project Management methodologies, Root Cause Analysis, Value Stream Mapping and Continuous Improvement principles. He or she will drive for continuous improvement and agility in the sustaining process ensuring that project timelines are consistently met.

 

Job Responsibilities:

 

  • Lead and manage multiple Research and Clinical Sustaining Engineering Projects
  • Manage a team of Project Managers and/or Contractors
  • Defines program priorities, resource needs, and negotiates program resourcing plans
  • Manage current challenges, work proactively on improving existing portfolio pipeline in collaboration with Sustaining Engineering Leadership Team
  • Ensures alignment of product value proposition, program scope, and strategic business objectives
  • Represents both internal and external customers viewpoint when leading the team to make technical and project decisions
  • Demonstrates program management best practices and contributes to improving sustaining process effectiveness
  • Champions novel ideas and problem solving skills
  • Leads the team to prepare for periodic update to Research and Clinical Instruments Leadership Teams, ensuring that decisions are informed by a balanced and clearly articulated representation of the relevant data
  • Leads program planning process ensuring requirements are clear and driven by customer need and/or challenges or issues
  • Defines, delegates and evaluates the roles, responsibilities, goals and deliverables for the program and extended team members
  • Communicates program updates to Functional Management, Sustaining Engineering Team and Executive Leadership as needed
  • Leads cross-functional teams through problem resolution including root cause analysis and corrective action
  • Creates and sustains an inclusive environment
  • Leads the program team to mitigate risks and resolve issues
  • Leads key technical and design reviews, and constructively challenges the team and the organization to rethink assumptions and approach challenges in new ways
  • Brings regulatory compliance and quality assurance questions and issues to the attention of management

     

     

    Minimum Qualifications:

    Education and Experience:

     

  • Bachelor’s Degree is required in Engineering and post graduate degree (e.g. MBA or Masters or PhD) is preferred
  • Black Belt or Design For Six Sigma and PMP are also preferred
  • Minimum of eight years of experience in a project or program management role
  • Experience managing small team of Project Managers
  • Track record of success in leading and managing sustaining engineering projects
  • Program/Project management experience in Instruments, Hardware, Firmware or Software areas is a must
  • Experience in life sciences, biotechnology medical device or diagnostic industries
  • Experience with methodologies such as Scrum or Agile or Waterfall is preferred
  • Experience in managing projects to meet changing regulatory requirements is preferred
  • Experience working in Design Control, Change Management, ISO and FDA environment
  • Understanding of regulations, standards and guidelines related to IVD, and/or medical devices and quality systems including 21 CFR, IVDD, IVDR, ISO14971, ISO13485, etc.
  • Experience managing external suppliers, vendors and contractors
  • Effective verbal, written and presentation skills required
  • Ability to travel up to 10%
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 

Share This Job

Powered by