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.
- 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.
- 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
- 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.
- 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.
- Bachelor Degree (BS) in mechanical engineering, biomedical engineering, or related field equivalent required; Advanced degree in field is desirable but not required.
- At least5years’ experience in V&V testingrequired.
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
- Thecapacity 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.
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.