Reports to: Senior Manufacturing Engineer
ESSENTIAL TASKS AND DUTIES INCLUDE:
· Designs, develops, troubleshoots and debugs testers and test procedures to support manufacturing and development of System.
· Develops hardware and software solutions used to test PCBA level and system level functional tests including but not limited to LabView PCBA testing, leak and flow testing, electrical testing and system functional testing.
· Work with Design and Manufacturing Engineering to develop test parameters/requirements to ensure that all design requirements are evaluated to minimize or remove all gaps in test coverage.
· Write and perform validation activites for new and existing production tests related to the implementation and validation of Production Test Equipment and fixtures.
· Create, implement and maintain test software in the LabView environment for existing and new programs.
· Implement and maintain existing and new leak and flow test equipment.
· Create, revise, release and maintain test procedures through controlled document change order procedures.
· Transition board level functional tests to contract assembly suppliers where applicable.
· Support Engineering team and Production team efforts to identify opportunities to streamline production through process, test and product design changes.
· Support Technical Service activites including system troubleshooting and upgrades.
· Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of cGMP’s, QSR and ISO requirements.
· Provide training in testing, troubleshooting and inspection methods as required.
· Perform other tasks and duties as required
BACKGROUND AND QUALIFICATIONS:
· Proven experience in fabrication and validation of test equipment/procedures of Electro-Mechanical and functional test equipment in a FDA/ISO regulated Medical Device/Medical Equipment Industry.
· Must possess expertise in electronic testing, troubleshooting and repair of printed circuit boards.
· Experience with IPC Standards including J-STD-001 Soldering Electrical and Electronic Components, IPC-A-610/620 PCB and Wire Harness Inspection and IPC-7711/7721 Rework and repair of electronic assemblies. Formal training/certification a plus.
· Must be detailed oriented with strong organizational skills and interpersonal skills with outstanding ability to communicate clearly and effectively.
· Knowledge of LabView programming, formal training a plus.
· Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.
· Must have effective analytical and decision-making skills with a keen focus on quality and accuracy to ensure that all work assignments meet corporate quality and regulatory requirements. Six Sigma formal training a plus.
· Ability to identify, prioritize and resolve issues as they arise with minimal supervision.
· BS in Engineering plus 2 years of experience or AS in Engineering plus a minimum 10 years of experience working in a FDA/ISO regulated Medical Device/Equipment Industry; or equivalent combination of education and experience.
Valid through: 12/16/2021