Staff Engineer, Change Analyst - Davie, FL - Stryker Corporation

Date de publication : 7/30/2020

Résumé de l'offre

Description de l'offre

The Staff Engineer, Change Analyst will provide technical leadership and direction in changes. Responsible for the oversight & assessment of changes to the quality management system. Will ensure CAD and drawings meet established cross-divisional criteria and align with procedures. Furthermore, support the continuous improvement of Stryker product development tools and processes.

Who we want:

  • Motivated product launchers. Individuals who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.

Will work within the Mechanical Engineering team, with general supervision and mentoring, with responsibility for quality-related activities, including, but not limited to the following:

  • Execute and/or Participate in the Change Control review forums and in multi-site forums.
  • Lead, facilitate, and mentor teams through all stages of the change control process.
  • Interface between functions /departments such as Design, Quality, and Operations in a product, process, system, or supplier related changes.
  • Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectiveness, and appropriateness
  • Liaise with Change Requester and SMEs during all stages of the Change Control process.
  • Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment, and oversight.
  • Monitoring completion of post-release tasks to ensure completion in a timely manner.
  • Drive initiatives for continuous improvement.
  • Drive cross-plant projects and participate in corporate project teams in areas of change control.
  • Manage Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums.
  • Lead and support the Change Analyst function across sites.
  • Mentors and coaches Change Analysts and Engineers.
  • Support the Change Manager role, where applicable.
  • Support in training needs related to the change control process
  • Support in the preparation, participate and follow up to Stryker Internal, Corporate, and third-party compliance audits.
  • Create ECN in onePLM for the owning group.
  • Determine ECN complexity using provided guidance.
  • Define an implementation plan with all change tasks specified in the Global Impact Assessment form.
  • Partner with change initiator and SMEs where necessary to ensure alignment of the implementation plan and original change request.
  • Partner with CAIIs from other sites for changes that also impact those sites.
  • Ensure a training plan task is included if required.
  • Determine whether approvals are required on an external task.
  • Ensure all attributes on the ECN and implementation plan are correct.
  • Verify that CAIII and the team assigned as CIB are correct for the change.
  • Assign tasks to Task Assignee(s).
  • Drive ECN to ensure all tasks are completed.
  • Review detailed drawings/specifications and ensure proper alignment to appropriate guidance and drawing rules.
  • Apply processes and Standards (i.e. ASME, ANSI, etc.)
  • Contribute and work diligently to project schedules. Clearly communicate the status of assignments, coordinate tasks/dependencies, and shift priorities as dictated by project demands.
  • Meet the needs of internal customers such as Electrical, Instruments, GQO, AO, and AQE, etc. as applicable for specific project assignments.
  • Work directly with users in user settings, clearly communicate design goals and user feedback to all stakeholders.
  • Have a good understanding of engineering and quality concepts/theories.
  • Excellent English (both oral and written), communication skills, and attention to detail.
  • Previous experience with Windchill, in industry desirable.
  • Understanding of Med Device concepts desirable.
  • Familiarity with ISO 13485, GDP, GMP concept desirable.
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.
  • Self-starter with an efficient work style and ability to handle multiple tasks in a fast-paced environment.
  • Must be willing to work as part of a multi-site team, with some travel required.
  • Problem-solving and analytical skills.
  • Builds strong relationships by fostering open communications, respect, and trust. Strong team player and acts with a customer service/stakeholder focused approach
  • Is diplomatic, tactful, and leverages excellent interpersonal keys to help achieve outcomes.
  • Accepts change openly and adopts a continuous improvement orientation to the role
  • Detail-oriented with excellent interpersonal and organizational skills.
  • Knowledge of Risk-Based and statistical concepts desirable.
  • Experience/exposure to 3D Modeling (Solidworks preferred), Drawing knowledge, GD&T, and associated principles/tools are highly desirable.

Education and Qualifications:

  • Bachelor’s degree in Engineering
  • 4+ years of experience with change control or document control (preferred in a regulatory environment; aerospace, medical device, automotive, etc.).
     
  • Preferred:
    • 4+ years of engineering experience.
    • Experience with Windchill.
    • Experience with new product development and release.
    • Experience in the bill of material (BOM) configuration.
       

Work From Home: Not available

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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