Description:
This position supports FERNO's Engineering Department in Wilmington, OH with emergency pre-hospital patient handling products. Primary responsibilities include support for both the Engineering and Production teams in the design, manufacturing, and supply chain of EMS products.
The Project Engineer will work closely with functional and cross functional team members in the global company including those in engineering, operations/production, product management, service, quality, and regulatory departments. The Project Engineer will be responsible for various portions of product development, product sustaining, quality assurance and manufacturing activities.
The Project Engineer will work autonomously with support from other engineers to ensure reliable components for a growing platform of powered EMS products. The Project Engineer will work with functional leaders internal to FERNO, contract engineering firms, contract manufacturers, vendors, and field service providers.
Requirements:
Essential Duties and Responsibilities
Primary functions/requirements:
- Responsible for the design, reliability, quality, supplier selection, supplier quality, of existing and new components and assemblies.
- Multiple project track record of management as engineer accountable to business for program success. NPI experience a plus.
- Exposure to and/or basic engineering understanding of design principles related to extrusions, castings, injection molds, control systems, circuit design, PCBAs, battery technologies, embedded firmware, metalworking, machining, hydraulics.
- Familiarity with compliance to global regulatory standards.
- Design/re-design of FDA, ISO 13485, ISO 14971, MDD 93/42/EEC, MDR compliant products.
- Participate in Engineering Change Order and/or Phase-Gate processes for assigned programs to include QMS compliance.
- Responsible for leading team through maintaining and updating design drawings and models utilizing Solidworks, PDM, and/or Altium. Prior expertise as a user highly preferred.
- Participate in formulation of design specifications, material specifications, concept, prototyping, tolerance stack-ups, DFM, DFA, DFS, vendor integration, design reviews, FMEA development, usability assessment, design transfer readiness and introduction.
- Review of product verification and validation test plans and results.
- Lead communication on assigned programs and provide issue escalation support to internal and external customers.
- Develop solutions to improve product quality and reduce product cost.
- Working knowledge of GD&T/ANSI drawing standards.
- Strong product affinity and results orientation.
- Assist in diagnosing field issues and developing corrective actions
- Perform FAI / Sample Approvals of R&D components
- Assist with qualification of new vendors and vendor processes
- Manage supplier rejections, SCARs, returns, and re-orders
- Assist with Bill of Material (BOM) management and inventory
- Generate inspection criteria and perform and document inspections of components accordingly
- Inventory management from incoming through disposition and/or obsolescence
Education and/or Experience
- Bachelor's degree in Engineering (preferred)
- Degrees in other disciplines will be considered depending on previous experience (eg, leading engineering teams) and/or credentials (eg, PMP or similar certifications)
- 8+ years related experience and/or equivalent combination of education and experience
PHYSICAL/SAFETY/TRAVEL REQUIREMENTS
- Job demands include prolonged sitting, may need to stoop, bend and stand as appropriate
- Requires coordination of hands and/or eye/hand/foot
- Meets cognitive demands to include visual discrimination/memory, auditory discrimination/memory reading ability, independent decision making and retention of specific knowledge.
- Requires use of safety glasses in designated areas
- Ability to travel up to 10%
Ferno is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.
Equal employment opportunity, including veterans and individuals with disabilities.
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