Test Engineer

Must haves: minimum 2 years of engineering experience, Solid works, execution hands on role, Engineering Degree

Nice to haves: Statistical Analysis Experience

Test Engineer

Synthesizes requirements and/or design specifications into testing solutions for disposable medical device products that acknowledge technical, schedule and cost constraints in support of R&D product development. Designs, develops and executes comprehensive test plans, procedures, schedules, and test protocols to evaluate the design per specifications. Reviews and evaluates test requirements to insure completeness of test program. Coordinates integrated testing activities including required labor, space, and equipment with appropriate areas or vendors. Provides assessment to engineers, technical lead, or project manager and adjusts plan as required. Compiles data and defines changes required in test equipment, procedures, processes, methods, or new testing requirements. Performs data analysis and documentation of test results. May participate in design of test fixtures and testing of prototypes or developmental assemblies or systems.

ESSENTIAL DUTIES:

Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Enter Responsibilities/Essential Duties:

Demonstrates solid/strong technical knowledge to independently select best methods and approaches to solve diverse and moderately complex problems and make accurate and effective technical decisions. Solves complex problems under close supervision or with assistance. Applies appropriate standards, processes, policies, procedures, and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOPs) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.

Develops and validates moderately complex test methods, executes testing protocols, and incorporates statistics and principals of experimental design.

Maintains R&D lab organization, calibration records, and performs preventative maintenance of equipment and test fixtures.

Identifies, procures, calibrates, and appropriately uses laboratory equipment and tools, and clearly documents, communicates, and summarizes technical findings and results.

Implements project management practices as needed; communicate proactively, openly and cooperatively within the department, team, and with supervisory staff to keep all informed. Prepares clear and timely written and oral status reports, updates, and technical presentations. Makes technical presentations to supervisors and small groups and may assist others with presentations.

Interfaces with product development team, suppliers, and other technical and support personnel. Applies and demonstrates understanding of customer needs, product use, and operational requirements to translate customer needs into testing design specifications and applications. Applies basic understanding of specialized and/or interdisciplinary technical areas, project management, and system design.

Clearly communicates instructions and technical specifications, both orally and in writing.

Proactively identifies, communicates, and refers problems or coordination needs to senior staff or supervisors. Exercising sound judgment of what to share, refer, and when to seek assistance, provides timely, accurate, and detailed background data to minimize risks or support problem-resolution or goal achievement.

Boston, MA*On-Site

AutoCAD Minitab Instron Machining Visionary Leadership Innovation Statistics Prototyping Calibration Coordinating Communication Data Analysis Presentations Test Planning Microsoft Word Test Equipment Systems Design Microsoft Excel Problem Solving Medical Devices Listening Skills SolidWorks (CAD) Project Management Microsoft PowerPoint Statistical Analysis Laboratory Equipment Design Specifications New Product Development Complex Problem Solving Technical Presentations Ultimate Tensile Strength Engineering Design Process Medical Device Development Verbal Communication Skills Standard Operating Procedure Troubleshooting (Problem Solving), Required: Bachelor’s Degree, BSE in technical field.

Preferred: Bachelors Degree in Mechanical, Biomedical, or Materials Engineering.

EXPERIENCE:

Required: 0-4 years experience with medical device development under FDA Quality Systems Regulations.

Preferred: Experience with machining and working in machine shop environment is a plus.

Proficiency:

Demonstrated written communication skills

Strong verbal communication and listening skills

Troubleshooting and problem-solving skills with hands-on practical expertise

Proficient with lab equipment appropriate to technical field such as microscopes, Instron tensile testers, chemical hood, and noise & vibration analyzers.

Proficient with Microsoft Word, PowerPoint, Excel, and Minitab.

Proficiency in design packages appropriate to technical field such as SolidWorks, eDrawings, and AutoCAD is desirable. Job Type & Location, Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.