- Investigate basic manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. (50%)
- Optimize Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. (20%)
- May develop, update, and maintain technical content of risk management files (10%)
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes (10%)
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinates technician work (5%)
- Heart Valve testing
- Valve preparation, valve hydrodynamic testing, valve awt testing, CAD, fixture design.
- Lab based skills
- Anything cardiovascular related
- Needs someone who is process driven.
- Strong written and verbal communication, interpersonal, and relationship building skills
- Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
- Strong computer skills, including usage of MS Office Suite
- Full understanding of equipment in a lab environment
- Ability to identify problems and relevant issues in complex situations, assessing using standard procedures
- Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such measuring equipment
- Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
- Knowledge and understanding of statistical techniques and procedures
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing
- Strict attention to detail
- Must be able to work independently including formulating work instructions and providing guidance and training to lower-level employees
Education and Experience: Associate's Degree or equivalent in technical degree/certificate , 2-4+ years experience previous experience in R&D Lab and/or medical device experience
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
To apply please email your resume to firstname.lastname@example.org