Essential Job Functions

Execute experiments and tests (following protocols) to develop findings for the

validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review.

Operate a variety of test equipment to assess characteristics of the manufacturing.

Compile documentation for archives to ensure appropriate documentation for

development work, including CRs, SOPs, drawings, and tooling, for Engineering

approval.

Consult with Engineers, Technicians, and Assemblers on processes to execute

experiments and/or production runs. Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.

Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems.

Collaborate with Engineering in the development of training and documentation

materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

Provide feedback to Engineering on potential opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes

Education/Experience

Technical degree/certificate in related field (electronics, electricity, mechanical, or engineering experience)

Required Skills

Basic written and verbal communication, interpersonal, and relationship building skills

• Good computer skills, including usage of MS Office Suite

• Ability to read and comprehend English sufficiently to understand work procedures and complete work documents

• Moderate knowledge of validation and improvement of automated equipment and procedures

• Ability to perform basic troubleshooting

• Ability to identify problems and relevant issues in straightforward situations, assessing using standard procedures

• Ability to use manufacturing, test, development or diagnostic equipment; use tools such as measuring equipment

• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions

• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to clean room medical device manufacturing

• Strict attention to detail

• Must be able to work in a team environment

• Ability to provide feedback in a professional, direct, and tactful manner

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.