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Danaher Corporation Sr Test Engineer - Design in Charleston, West Virginia

Mammotome associates know that every moment matters when it comes to cancer diagnostics. When we come to work, we’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our team as a Senior Test / V&V Engineer and support products you can feel passionate about! Learn more about Mammotome at www.Mammotome.com.

This position is based in Cincinnati, Ohio. Relocation assistance is available.

Senior Test / V&V Engineers support New Product Development (NPD) and Sustaining Engineering projects by providing design Verification and Validation of a product’s user, performance and technical requirements. While collaborating technically and programmatically with project teams to design and develop test systems and methods, V&V Test Engineers have responsibility for independently directing and executing test activities to ensure product quality, reliability and regulatory compliance.

Responsibilities we will trust you with:

Verification/Validation Planning

  • Works with project teams/owners to select and develop requirement sets that are complete, unambiguous and testable.

  • Works with project teams to establish Verification/Validation plans that support NPD and Sustaining Engineering project schedules. Creates and maintains the Design Verification and Validation plans (DVP&R) for each assigned project.

  • Applies Reliability Engineering principles to develop test plans that will proactively predict and promote product reliability growth.

  • Develops and organizes testing schedules, coordinating Verification and Validation resources and lab capacity.

Test Design & Development

  • Serves as a subject matter expert for test system design, development and equipment selection through expert knowledge of both electrical and mechanical testing systems.

  • Independently designs, develops, fabricates, and verifies test fixtures or acquires specialized and general purpose test equipment.

  • Creates complex test systems for product testing using a variety of lab tools (i.e., Instron, Torsion Master, LabVIEW, breadboard designs, strain gages, etc.).

  • Develops plans for test system verification and executes GR&R studies for test system verification.

  • Interprets GR&R of measurement systems and identifies potential improvements.

  • Develops standard and specialized test methods and work instructions to define Verification/Validation testing. Writes test protocols in accordance with Verification/Validation plans.

Test Execution

  • For assigned projects, conducts and/or oversees mechanical, electrical, electromechanical, and simulated use testing performed in the R&D Lab.

  • Directs and coordinates outside testing in the areas of:

  • Environmental & Transit

  • Pre-Clinical (Animal Testing)

  • IEC 60601-1 Compliance

  • Usability

  • Product Durability/Reliability

Test Analysis & Reporting

  • Prepares and submits Verification/Validation completion report(s) for assigned projects.

  • Prepares the Verification/Validation summary reports for assigned R&D and Sustaining Engineering projects.

  • Analyzes test failures and collaborates with project teams to identify design solutions.

  • When applicable, documents appropriate non-Verification/Validation testing in appropriate engineering studies.

Test Systems Maintenance & Documentation

  • Maintain systems to ensure test methods are standardized, fully documented and retained in the Company’s Document Management System.

Leadership

  • Provides mentorship to less experienced engineers and technicians.

  • Establishes and maintains relationships with project technical leads that balance collaboration with independence.

  • Seeks and promotes opportunities for continuous improvement in V&V processes and capabilities.

  • Promotes a culture of rigorously discovering product performance and reliability limits while balancing project and business objectives.

  • Evaluates external testing resources for quality, capability and delivery.

Your areas of knowledge and expertise that matter the most:

  • Bachelor Degree (BS) in mechanical engineering, biomedical or electrical engineering, or related field equivalent; Advanced degree in field is desirable but not required.

  • Minimum of 5 years ’ experience in product verification and validation testing

  • Statistics - Experience with basic hypothesis testing and Design of Experiments (DOE) preferred. Ability to study the collection, organization, analysis, interpretation, and presentation of data.

  • Knowledge in the application of medical device design controls and development processes as defined by ISO 13485 preferred.

  • Knowledge of Reliability engineering principles including Design for Reliability (DfR) methodology, reliability modeling, accelerated life testing, and uncertainty quantification.

  • Ability to understand engineering design issues in order to properly interpret test data generated. Ability to conceptualize designs as they relate to test fixture and test equipment capabilities. Able to develop new or refined applications of engineering principles used in analysis and resolution of technical issues during product development process

  • The capacity to plan, organize, & complete projects on time. Excellent project management skills and ability to juggle multiple responsibilities and deadlines

  • Ability to lead teams and drive change in a matrix organization

  • Technical writing experience helpful

  • Experience with Medical device development and testing preferred

What we have to offer:

Check out our benefits here: www.danaherbenefits.com

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.

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When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

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