Manufacturing Engineer - Medical Device
Kforce Inc.

Job Info

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RESPONSIBILITIES:

Kforce's client, a growing Medical Device Company in Encinitas, CA is seeking a Manufacturing Engineer within the Medical Device Industry. We are working directly with the Hiring Manager on this exclusive search assignment. This company offers a competitive compensation package including base salary, annual bonus, and Stock. The Console Manufacturing Engineer will be responsible to lead and support new product and development activities on the console. This individual will be responsible for the design, development, implementation, and control of new and improved manufacturing processes for medical device. They will provide daily support of products, processes, materials/supplier management, and equipment for new and sustaining products.Responsibilities:

• Create and implement new manufacturing processes and testing of console/capital equipment
• Work with suppliers around the world to understand and define their manufacturing process, equipment, tools/fixture to ensure quality products are being delivered
• Perform characterization, Design of Experiments (DoE), Test Development, and write/perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ)
• Create manufacturing documentation including work instructions, forms, BOMs, routers, FMEAs, DMR, and DHF documents, test methods, test procedures, etc.
• Support production on both sustaining activities and new products development from line setup through commercialization
• Support production and own NCR, CAPA, and/or investigations
• Innovate, design, and develop processes, procedures, tooling and/or automation
• Train and provide direction to direct reports and manufacturing personnel
• Drive functional excellence initiatives for product/process and technical development

REQUIREMENTS:

• BS degree in Engineering preferably Mechanical or Electrical or similar field
• 3-5+ years medical device experience in process/manufacturing engineering role
• Experience in Design for Manufacturing (DFM), Lean Manufacturing, Mechanical Design, Design of Experiments (DoE), and technology/process transfer experience
• Experience with product/process failure mode and effects analysis (FMEA), and problem-solving methodologies
• Broad knowledge of assembly, and test methodologies and associated equipment
• Understanding of medical device design controls/quality system and product development processes
• Experience in a regulated environment; Preferably medical device
• Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements
• Excellent verbal/written communication skills
• Ability to organize, records, and implement procedures
• CAD software example: Solid Works is highly desired
• Highly self-motivated individual with a collaborative determination to achieve set goals
• Experienced with creation and implementation of new manufacturing processes, equipment/fixture, tools, and documentation for disposable and/or capital equipment medical devices
• Experienced in process development, supply chain, supplier process development/optimization

Nice to have but not required:

• Experience/knowledge of mapping, localization, electronic assembly, power electronics, Cabling/Connector Design

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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