Purpose To conduct test engineering assignments on new and current products Collaborate with other Operations, Engineering and Quality staff to test, launch and manufacture products that satisfy market specifications and end-user requirements. Conduct these activities according to ISO & IEC 60601-x compliant standards and to FDA medical device product development processes. You will be part of an interdisciplinary design, development and manufacturing team. Assist engineers in Operations, Engineering and R&D with various investigations, testing, and applications of electronic medical devices. Tasks will include specification, execution and documentation of experiments; analysis of data; device/system testing; design, implementation and operation of test fixtures. Additional tasks may include: design & development of laboratory-instrument control software and mechanical modeling. Responsibilities:
Developing and executing methods and procedures to test and inspect product quality
Developing and fabricating test and assembly fixtures, draft procedures, and automated test programs.
Supporting manufacturing operations for Biosensor and Tablet Testing
Compiling, assessing, and analyzing production test data
Suggesting corrective action for procedures and product deficiencies
Building manufacturing methods to meet design goals on new or enhanced products
Suggesting new processes to enhance overall efficiency
Setting up routine maintenance schedules and suggest periodic upgrades of test equipment and fixtures
Liaising between Manufacturing, Engineering and contract manufacturers on test development
Defining test strategies, analyzing new product testability, delivering test solutions to manufacturing partners
Introducing new products on schedule by coordinating with Design Engineering and Program Management
Developing and executing test processes to support needs and permit future growth
Introducing test processes, monitoring functional test yield, taking corrective actions, and suggesting cost reductions
Apply electrical and mechanical engineering skills, in a collaborative team, to perform sustaining engineering tasks for released products.
Understand and interpret electrical schematics, component data sheets, and mechanical engineering drawings.
Prepare and review documentation to support design history files (DHFs). Prepare production assembly instructions, and production testing procedures in accordance with cGMP standards.
Maintain and improve existing product manufacturing processes. Anticipate Manufacturing’s need for new products and fixtures.
Specify, design, and develop test systems supporting product test and manufacture. Coordinate with subcontractors in the design and development of product subsystem and PC board–level test fixtures.
Survey and identify replacement components for reasons of obsolescence or cost reduction. Identify and contact vendors. Compare technical specifications. Compile and prepare required documentation.
Conduct failure mode investigations (FMEA), and risk analysis of medical devices according to FDA QSR and international requirements.
Run lab tests to evaluate and characterize electronics components and systems (collect and analyze measured data).
Coordinate with off-the-shelf and custom component vendors to maintain overall quality. Specify and document custom-component characteristics and required performance.
Travel to contract manufacturer and suppliers as needed to support product manufacturing. Participate as technical representative in vendor audits.
Understand basic electronic principles and the function of common electronic components.
Read and understand electronic system schematic drawings and block diagrams.
Use common test electronic laboratory test equipment (oscilloscopes, power supplies, meters, etc.).
Degree in Computer Science or Electrical Engineering preferred
Associate: 0-2 years’ experience
Senior: 3-8 years’ experience
Staff: 5-12 years’ experience
Principal: 8-15+ years’ experience
Experience manufacturing devices according to FDA and ISO 13485 requirements. Some knowledge of IEC 60601-x or equivalent specifications, strongly desired.
Knowledge and Training
Experience with medical devices in an FDA-managed environment
Experience with hardware and software test development
Experience with transfer of medical electronics products into manufacturing.
Ability to assess the feasibility of process modifications to improve manufacturing quality and throughput.
Experience in troubleshooting and recommending corrective or preventive actions to improve manufacturing processes and product reliability.
Experience with electronic product repair and servicing. Work with hand tools, SMT solder stations, power supplies, multimeters, oscilloscopes, function generators, current probes, signal analyzers, in-circuit programmers, and other test instruments.
Results oriented self-starter. Ability to prioritize tasks and multiple projects simultaneously. Ability to work independently. Ability to work well with others in a team setting.
Good communication skills, verbal and written.
Strong interpersonal and collaborative skills. Works well as a supportive team member.
Experienced in interfacing with functional groups outside of Operations and Engineering.
Basic knowledge of electrical circuits and instrumentation.
Proficient in computer systems: Microsoft Word, Excel. Experience in OrCAD schematic capture or equivalent. Experience in mechanical CAD SolidWorks or equivalent is a plus.
Experience with LabView instrument control software. Experience with general purpose software languages, development tools and systems is a plus.
Ability to self-manage time. Ability to prioritize and handle the demand of multiple tasks. Ability to operate independently with a moderate amount of direction.
Excellent verbal and written communication skills.