Staff Metrologist in Kalamazoo, MI at Stryker Corporation

发布日期: 11/8/2020

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职位描述

Who we want
Dedicated achievers. 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.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As a Staff Metrologist, you will be responsible for implementing the Stryker Shared Services measurement and inspection strategy, based on principles of measurement science and regulatory requirements. Supporting business inspection needs through technical analysis of measurement problems, accuracy and precision requirements. Supporting the process of creation, optimization and qualification of inspection methods in Stryker facilities.

Responsibilities

  • Work within the QA Shared Services Metrology Team
  • Supporting and conducting engineering and metrology research including the identification, investigation and implementation of new advanced metrology and inspection systems and technologies
  • Coaching and advising all engineering groups on analysis of inspection data, gage R&R results and inspection methods to establish optimum process parameters
  • Develops continuous improvement and management tools for Metrology processes
  • Redesigns or adjusts measurement capability to minimize errors.
  • Advising engineering groups including Supplier Quality on methods of resolving measurement problems / conflict.
  • Applying proven principles to known situations and evaluate unexpected or contradictory results
  • Site SME / owner of Metrology procedures including MSA
  • Providing technical support for QA/OPs on inspection techniques, inspection measurement and test equipment and technologies.
  • Advising AO and R&D Metrology on optimization of new product prints finalized to DFI
  • Act as site SME / owner of Metrology procedures including MSA, ensure compliance to corporate and regulatory requirements and industry best practices
  • Supporting the day to day and long-term strategy for Metrology activity in Stryker facilities.
  • Being the technical and strategic reference point and expert for QA/OPs for Metrology Support
  • Supporting alignment of Stryker sites to sourcing, purchasing, implementation and management of measurement systems.
  • CMM inspection program creation and qualification
  • First Article Inspection of product
  • Routine inspection of vendor and internally manufactured implants for development or investigative purposes
  • Metrology support for complaints, NC and CAPA investigations
  • Inspection and calibration of internal and vendor custom gauging
  • Supporting engineering, quality and laboratory personnel in design through on geometric tolerancing, tolerance stack-ups and gauge design
  • Being able to challenge Vendor and Internal Designers on the interpretation of product design drawings
  • Being able to generate CAD drawings and apply GD&T tolerancing principles to the ASME Y 14.5M 1994 (R 2004) Standard

What you need

Basic Qualifications:

  • Bachelor’s Degree in Biology, Microbiology, or a closely related life science required with 5+ years metrology related work experience
  • MS in science related field with 3+ years metrology related work experience
  • Ph.D. with 2+ years of metrology related work experience

Preferred Qualifications:

  • Experience in the application of Technical Standards, principles, theories, concepts & techniques
  • Previous experience in CMM operation and inspection software programming essential
  • Knowledge of applied statistics principles essential
  • GD&T experience/qualification essential e.g. ASME Y14.43 and must be able to read and interpret detailed mechanical prints
  • Demonstrated ability to carry out detailed reviews of processes in line with external standards and regulatory requirements
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required
  • Thorough knowledge and understanding of US and International Medical Device Regulations
  • Ability to identify and challenge non-value-added inspection
  • Generate CAD drawings and apply GD&T tolerancing principles to the ASME Y 14.5M 1994 (R 2004) or equivalent standard
  • Attention to detail and accuracy when completing documentation is required
  • Advanced PC skills, with focus on MS Office
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
  • Must possess strong communication, project management and influencing skills as well as manage multiple tasks simultaneously.
  • Strong interpersonal skills, written, oral communication and negotiation skills.
  • Knowledge of local and divisional products/processes within the manufacturing and testing environments an advantage
  • Highly developed problem solving, and strong analytical skills required
  • Some travel may be required
  • Demonstrated ability to identify and challenge non-value-added inspection
  • Must be capable of spending long periods of time programming, debugging and validating complex inspection equipment
  • Ability to work on own initiative and as part of a team in a fast paced, results oriented environment.

Work From Home: Occasional

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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