Senior Engineer (Medical Devices)
Roth Staffing Companies

Job Info

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Roth Staffing is looking for a Senior Engineer within the medical technologies firm. This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.

The client has an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and company's systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Job Responsibilities:
* Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
* Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
* Participate in design and drawing reviews to ensure that components meet requirements for design and patient safety requirements.
* Develop, validate, and improve component inspection strategies and methods to ensure parts meet drawing requirements.
* Responsible for defining supplier qualification requirements for components and custom materials, including supplier validations, company's receiving inspection test methods and fixture design.
* Develop, update, and maintain technical content of part qualification plans and reports.
* Investigate complex manufacturing product quality and compliance issues (e.g., NCR, CAPA, SCAR) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, implement corrective actions, and document reports.
* Perform other duties and responsibilities as assigned.

Skills:
* Effective communication and conflict resolution skills, team player
* Highly organized and detail oriented.
* Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
* Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR's and SCAR's
* Ability to make sketches, engineering drawings and common computations.
* Ability to read and interpret technical drawing, schematics and computer-generated reports.
* Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
* Understanding of Risk Management principles
* Previous experience with Keyence routine programming
* Six Sigma Green or Black Belt/LEAN Manufacturing experience a plus
* Ability to manage competing priorities in a fast-paced environment
* Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Education/Experience:
* Bachelor's degree (Engineering or Science) is required with 4 years of experience required or Master's Degree (Engineering or Science) and 3 years of related experience required

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. 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.

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