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Principal Product Engineer

Irvine, California
Job Type
15 Feb 2021
Principal Product EngineerAbout US At Vyaire, we help the world breathe easier. As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are a young company with a long history of revolutionary products. We devise extraordinary solutions that allow patients to lead ordinary lives. We believe the best way to create value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen. We are dedicated to anticipating what's next and get it done. We thrive on contributing and making a difference.To learn more, visit our website: our video: this role Vyaire teams are dedicated to connecting clinicians and patients with the highest quality respiratory healthcare solutions in the market. At Vyaire, you will find a company that puts the customer at the center of all we do. Our culture is one that rewards performance and each interaction we have with a customer furthers our mission to be the global leader in respiratory care.As a Principal Product Engineer, you will be responsible for designing, developing, and sustaining manufacturing processes to meet or exceed operational performance expectations. This role uses best practices and knowledge of internal or external business issues to improve products or services. The role is expected to solve complex problems and to provide new perspective using existing solutions. The role works receives minimal guidance and acts as a resource for colleagues with less experience.Essential Functions:The role requires conceptual and practical expertise in manufacturing and engineering in a medical device Class II or Class III manufacturing system and basic knowledge of other departmental roles/responsibilities.Proactively identifies opportunities and develops plan to deliver process performance improvements related to Safety, Quality, Delivery, and Cost of a Test process or line.Builds knowledge of the company, processes and customers by solving a range of straightforward problems and analyzes possible solutions using various analytical tools and methods. Identifies activity and assignment criticality and adjusts priorities when appropriateFollows and observes all regulatory and Quality Management Plan requirements (GMPs, ISO, FDA, Internal policies) applicable to area of responsibilityDetermine root cause and provide actionable resolutions to improve existing Test processes and equipment.Understand, maintain, and update risk management documentation associated with various Test processes and use information to evaluating product impact of changes.The role is expected to recommend data to collect, provide analytical support needed to analyze a problem, situation or issue, and provide guidance on next steps to achieve resolution of the issues. Develops strategy, change management plan, and execution plant to improve flow of products.Allocates appropriate amounts of time for completing own and other's work; avoids scheduling conflicts; develops timelines and milestones. Works hours necessary to complete assigned tasksAuthoring, reviewing, and executing equipment qualifications of existing and new validated equipment to support capacity improvements or to meet/exceed production service level expectations.Non-conformance resolution of a variety of issues and performing or implementing the containment, bracketing, root cause investigation, and corrective action. The role is expected to support both internal and external Test equipment as required.Initiate and review Engineering Change Request (ECO's) to implement changes to production documents such as drawings, bills of materials, and procedures.Perform validation execution and post-launch support of new products including identifying and documenting failure modes, the frequency of failures, and participating in root cause investigations.Willingly incorporate new and innovative work processes and ideas into daily work, demonstrating awareness and support of operational excellence initiativesBuild team effectiveness skills within own work team, demonstrating respect and appreciation for different perspectives and the diversity of othersYou will have the opportunity to: Demonstrate knowledge of Engineering principles and technologies supporting production delivery targets and supporting gross margin improvement projectsImprove production line efficiency and yield improvements utilizing Lean principles and tools, evaluating and improving process capability, and creating workflows that minimize work in progress and inventory.Leverages process knowledge to identify opportunities/solutions to improve throughput capacity by reducing impact of constraintsServe as a credible resource to interpret procedures and act as a resource for colleagues with less experienceLearn ERP systems and the financial and logistical interactions of work orders, drawings, Bill of Materials, cost of goods sold, and standard hoursQualifications:Demonstrating a persistent and appropriate bias for action. Maintains high work and ethical standards despite pressing deadlines and does work right the first timeSets a cooperative tone within the work group and across groups to get the work doneIdentifies and collects the necessary data to Cleary define the issue. Creates relevant options for addressing problem and achieving desired outcomeDemonstrated ability to clearly convey information and ideas to individuals or groups that assures comprehension of the message.Establishes course of action for self to ensure that work is completed efficientlyVolunteer for assignments when made aware of opportunities; seeks out learning opportunities to expand basic knowledgeBachelor's degree or equivalent experience in related field required6-10 years related work experience requiredAbility to follow instructions accurately and work as a member of a teamTravel: Up to 20% of timeIrvine, CAFull time
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  • Job Reference: 231975655-2
  • Date Posted: 15 February 2021
  • Recruiter: Vyaire Medical Payroll LLC
  • Location: Irvine, California
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent