Provides technical manufacturing support to Operations and Engineering.
**Key Responsibilities**:
- Execute experiments and tests (following protocols) to develop findings for the validation and improvement of equipment, software 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 ECRs, 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
- Other incidental duties
**Education and Experience**:
**Other**: in Technical degree/certificate in related disciplineelectronics, electronical, mechanical or engineering experience Required
Manufacturing and/or medical device experience Preferred
**Additional Skills**:
- Good computer skills, including usage of MS Office Suite
- Basic written and verbal communication, interpersonal, and relationship building skills
- Moderate knowledge of validation and improvement of automated equipment
- Ability to troubleshoot manufacturing equipment
- Basic knowledge of material compatibility in the proposed use environment
- Moderate knowledge of routine preventive maintenance of production equipment
- Moderate knowledge electrical, mechanical, electronic, pneumatic, and controls
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- Strict attention to detail
- Must be able to work under limited supervision
- 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
