Costa Rica-Heredia
Hybrid Roles:
About the role
Responsible for test development strategy and requirements. Plan and schedule the entire test development process. Define, design & oversee the manufacturing, fabrication, assembly, checkout, support, and validation of special automated test equipment. This includes scheduling, resource allocating, interfacing with cross functional team, writing test requirements, test specs, test software, test procedures, validation plans and reports. Scope of equipment - R&D verification and validation and production test equipment for both new product development and existing product sustaining.
Your responsibilities include:
- Interface with Digital Hardware, Analog Hardware, and Software Design Engineers to define test strategy and critical performance parameters for testing different levels of product assembly (i.e. PCBA, device level).
- Work with R&D engineers to design testability into new products.
- Work in conjunction with design engineers, manufacturing engineers and quality engineers to write test requirements, test specifications & test procedures.
- Be an ATE functional representative in the product design team.
- Generate related documents such as manufacturing test specifications, test software requirements, software intended use Test procedure, validation plan and report.
- Train test technicians on proper execution and troubleshooting.
- Work with suppliers to develop/improve their test methods.
- Design test equipment, mainly automated test equipment (ATE), including overall system design, digital and analog circuit design and instrumentation specification, test software programming.
- Supervise the design, fabrication and troubleshooting of functional test fixtures/stations.
- Validate test systems and test fixtures in FDA-regulated medical environment.
- Support verification and validation testing of products. Oversee the test system validation and quality buy-off. Other duties as assigned, such as core team membership, assistance for production/supplier troubleshooting.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
What we’re looking for:
- Bachelor’s degree along with 7+ years of hardware test engineer or related experience or 5+ years with a master’s degree or advanced degree, preferably BS/MS in Electrical or Electronics Engineer, or equivalent.
- In-depth knowledge of Product development life cycle and test methodology.
- Strong written and verbal communication skills.
- Strong analytical and problem-solving skills.
- Desired English level: C1+ 90 - 99%
- Please submit resume in English
Preferred Qualifications:
- A strong product quality and test lead experience preferably in medical device domain.
- A natural attention to detail and a penchant for organizing and documenting.
- A good learner who can master complex software and quickly adapt to new tools and technologies.
- Ability to think logically and analytically in a problem-solving environment.
- Ability to work independently as well as work collaboratively as part of a team.
- Demonstrated experience communicating both technical and non-technical information across teams and departments.
- Follow company policy regarding ISO and FDA documentation and compliance for medical device