Sr. Electromechanical Manufacturing Engineer (FDA)

RESPONSIBILITIES:
Kforce has a client in need of a Senior Electromechanical Manufacturing Engineer (FDA).

Responsibilities:
* Create and implement new manufacturing processes for medical devices
* Collaborate with global suppliers to define manufacturing processes, equipment, and tools/fixtures to ensure quality products
* Perform characterization studies, Design of Experiments (DoE), and validation/verification of processes and inspection methods (IQ, OQ, PQ)
* Develop manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents
* Lead teams of engineers and technicians on manufacturing activities
* Innovate, design, and develop processes, procedures, tooling, and automation
* Train and provide direction to manufacturing personnel
* Drive functional excellence initiatives for product/process and technical development
* Monitor KPIs/metrics and implement improvement projects as needed
* Assist in developing department budgets, schedules, and resource plans
* Perform other duties as assigned

REQUIREMENTS:
* Bachelor's degree in Engineering (Mechanical, Electrical, or related field)
* 6+ years as a process/manufacturing engineer in a regulated environment; FDA experience in pharma or medical device industry required
* Expertise in Design for Manufacturing, Assembly, and Test (DFMAT), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer, FMEA, and problem-solving methodologies
* Strong understanding of Quality Management Systems, design controls, and product development processes
* Solid knowledge of FDA regulations, guidelines, and policies for medical devices
* Experience with electromechanical systems and durable materials required
* Proficiency with CAD software (SolidWorks preferred)
* Excellent verbal/written communication and organizational skills
* Six Sigma Certification preferred

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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