Engineer II, Manufacturing Process
Position Overview
Support development and manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts and/or prototypes meet their requirements. Create and/or support projects focused on development of process engineering and quality systems. Lead and/or support execution of projects related to capital equipment builds. Evaluate, initiate, and create improved engineering and project systems for procurement and execution of capital equipment builds. Provide engineering support in areas of mechanical design, manufacturing process development, and capital equipment assembly processes.
1. Manufacturing support for existing processes and for new products, product changes, line extensions and enhancements, as well as related tooling and fixtures
2. Support validation of product, equipment, and processes
3. Interface with other departments to solve manufacturing production problems
4. Monitor equipment maintenance program
5. Investigate and test product processes
6. Support prototype and Pilot Production, Facilities, and Planning when appropriate
7. Lead manufacturing efforts associated with new product transfer between R&D and manufacturing
8. Evaluate, create, and initiate improvements to existing engineering and project systems
9. Provide support with execution of capital equipment build projects, including technical documentation (drawings, BOMs, specs, reports), builds procurement, and customer interaction
10. Work closely with prototype lab and Machine Shop to provide clear documentation and communication and allow for efficient fabrication
11. Develop documentation expertise related to equipment mechanical design and manufacturing processes
12. Search and implement new technologies to improve manufacturing processes and equipment design
13. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
14. Perform additional duties as assigned
1. Manufacturing support for existing processes and for new products, product changes, line extensions and enhancements, as well as related tooling and fixtures
2. Support validation of product, equipment, and processes
3. Interface with other departments to solve manufacturing production problems
4. Monitor equipment maintenance program
5. Investigate and test product processes
6. Support prototype and Pilot Production, Facilities, and Planning when appropriate
7. Lead manufacturing efforts associated with new product transfer between R&D and manufacturing
8. Evaluate, create, and initiate improvements to existing engineering and project systems
9. Provide support with execution of capital equipment build projects, including technical documentation (drawings, BOMs, specs, reports), builds procurement, and customer interaction
10. Work closely with prototype lab and Machine Shop to provide clear documentation and communication and allow for efficient fabrication
11. Develop documentation expertise related to equipment mechanical design and manufacturing processes
12. Search and implement new technologies to improve manufacturing processes and equipment design
13. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
14. Perform additional duties as assigned
Job Details
Job ID 13472BR
Aliso Viejo, California, USA
Salary Range:
$74,733.93 - $82,667.41 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)
- Required Qualifications
1, Bachelor’s degree in Engineering or related field
2. Minimum of four (4) years of related experience
3. Ability to read and prepare technical documentation
4. Working knowledge of standard machine shop equipment and processes
5. Knowledge of medical and technical development.
6. Proficient computer skills including MS Word, PowerPoint, Excel, and A-CAD or SolidWorks
7. Ability to diagnose and repair electrical malfunctions on process tools and equipment.
8. Statistical knowledge
9. Excellent written and verbal communication skills with ability to effectively manage internal and external customer relationships
10. Ability to present proposals to end-users of technology, equipment, tools/fixtures to achieve user acceptance, and negotiate with customers and vendors
11. Ability to work in a fast-paced, cross-functional environment
Desired Qualifications
1. Green Belt or Black Belt certification
2. Ability to use and apply lean management principles to analyze, improve and create engineering project and quality procurement systems
3. Experience working with manufacturing process development projects and transfer of R&D projects into high volume production
4. Ability to prioritize and meet deadlines in a timely manner
EEO
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.
Fair Chance Ordinance
If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.