Work with product design engineering and manufacturing to develop, review, analyze, and validate systems used in the manufacturing and testing of Automated External Defibrillators (AED) and related accessories. Lead and/or work with a team to improve and streamline production lines.
(1) Test Hardware design and development;
(2) Ability to assess product and system performance
(3) Demonstrated abilities supporting system and process validation throughout product lifecycle
(4) Project management skills with the ability to work with cross functional teams
(5) Knowledge of tools and processes related to risk management
(6) Experience defining and documenting validation tests, including peer review and maintaining traceability to requirements
Candidate must have the following:
(1) Demonstrated leadership skills with ability to complete a project, lead a team, and take ownership of issues
(2) Ability to provide guidance and direction to less experienced technical personnel
(3) Excellent problem solving skills;
(4) Able to complete a project independently or with a team;
(5) Able to organize and prioritize work load under pressure and time constraints;
(6) Able to communicate and interface effectively with other functional groups of the company;
(7) Able to effectively write procedures and reports;
(8) Conscientious about quality of work;
(9) Motivated to learn new things, self-starter, and interested in the AED business.
BS/MS Electrical Engineering or strongly-related discipline;
Preferred, Five or more years engineering experience in a highly regulated environment (FDA, FAA, etc.).
Understanding of equipment Validations.
Very effective in a highly regulated environment;
Able to produce results in all facets of production – NPI, design, support, and troubleshooting. Cross functional experience preferred;
Strives for excellence;
Ability to lead;
Excellent oral and written skills.
Preferred Technical Skills:
(1) Experience or knowledge working in a manufacturing environment and test system development;
(2) Proficient in circuit design, schematics and layout tools;
(3) Software programming skills
(4) Design for Manufacturing (DFM), Assembly (DFA), and Test (DFT);
(5) Knowledge of Test Method Validation, Design of Experiment (DoE).