Senior Test Engineer - Medical Device in Cincinnati, Ohio at Mammotome

Date Posted: 8/29/2019

Job Snapshot

Job Description

Job ID: MAM000692

About Us

At Mammotome, we are committed to providing best-in-class technology to help clinicians accurately diagnose breast cancer. We provide clinicians devices spanning the breast cancer diagnostic care continuum from tissue biopsy to accurate lesion removal, never forgetting that at the heart of each breast cancer diagnosis is the patient. Through our ever-expanding product portfolio we strive every day to improve the patient’s journey and achieve better outcomes. Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. 



Description

Test 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.


Essential Functions


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.

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.
  • Independently identifies, specifies, and 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 develops and interprets GR&R studies for test system verification.
  • Applies statistical thinking in test system design and in the determination of sample size and criteria for success.
  • 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.
  • 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

  • Implement systems to ensure:
    • Lab equipment is maintained and calibrated in accordance with manufacturers’ recommendations.
    • Test fixture and equipment assets are appropriately identified, stored and retrievable.
    • Test methods are standardized, fully documented and retained in the Company’s Document Management System.
    • Test fixture designs are fully documented and maintained in the Company’s Product Data Management System.
  • Other duties as assigned.

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.


Job Requirements



Qualifications

Required Education & Experience
  • Bachelor Degree (BS) in mechanical engineering, biomedical engineering, or related field equivalent required; Advanced degree in field is desirable but not required.
  • At least 5 years’ experience in V&V testing required.

Critical Success Factors

  • 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.
  • 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
  • Excellent communication skills, both written and verbal
  • 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
  • Action oriented individual who is highly proactive at solving problems and obtaining results.

Desired Skills / Experience

  • Experience with Medical device development and testing
  • Demonstrated knowledge and experience in reliability engineering

Occasional Travel Possible.

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Diversity & Inclusion

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.





Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.