Job DescriptionResponsible for supporting medical devices for both existing and new product development, production, and processes. This includes creating or verifying specifications, maintaining, and enhancing product processes, and designing fixtures and equipment, testing processes, equipment, test methods and raw materials to ensure that the concepts and prototypes meet their specifications. Lead and support projects related to new product introductions, process development engineering, quality systems improvement, and other engineering tasks. Evaluate, initiate, and establish improved engineering and process validation. Job duties:
- Provide manufacturing support for existing processes, new products, product changes, line extensions, enhancements, and related tooling and fixtures.
- Support validation of product, equipment, and processes.
- Collaborate with other departments to ensure readiness for process validation.
- Draft and execute validation of product, equipment, and processes.
- Evaluate, create, and initiate improvements to existing engineering and project systems.
- Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
- Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
- Set up and initiate new manufacturing line(s), including purchasing, implementing, and validating new equipment.
- Review and develop manufacturing documents (e.g., MP, BOM, pFMEA, etc.).
- Develop documentation expertise in equipment mechanical design and manufacturing processes.
- Seek and implement innovative technologies to enhance manufacturing processes and equipment design.
- Lead projects and may supervise Engineers, Technicians, or others as needed.
- 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.
- Perform additional duties as assigned.
Qualifications- Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering or related field.
- A minimum of four (4) years of relevant manufacturing process development experience in the medical device industry.
- Strong written and verbal communication skills.
- Proficient computer skills including MS Word, Excel, Outlook, Teams, and CAD.
Desired Qualifications- Advanced degree in Engineering or related field.
- A minimum of (6) years of relevant manufacturing process development experience in the medical device industry.
- Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development, characterization, and optimization preferred.
- Proven knowledge of Lean/Six Sigma techniques (Green).
- Ability to solve complex manufacturing problems.
- Ability to read and prepare technical documentation.
- Knowledge of medical and technical development as well as international regulations for medical devices.
- Strong problem solving and conflict management skills.
- Proficiency with SolidWorks and fixture design preferred.
Physical- Extended periods of computer use.
- Extended periods of sitting or standing.
- Light lifting, up to 25 lbs.
- May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
- Some travel required.
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.
Salary Range$105,067 - $125,900 (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)
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