Warning: Avoid fraudulent jobs and phishing scams, some work from home jobs and any job that asks you to pay to apply! More Info
Duties:
• Plan, design and develop new, existing or modified product concepts from R&D development lab into production. Project Leader responsibilities.
• Leads projects for one or more product development projects for medical devices to achieve on-time results and according to plan.
• Provides technical input for projects at all stages of the product life cycle.
• Take customer concepts & conducts design verification at various stages of the design process to ensure consistency between the outputs against the requirements
• Project management & documentation with design controls, risk analysis, etc in accordance with established SOPs.
• Creates performance and functional requirement specifications to comply with ISO standards
• Prepares design layouts and detailed drawings in support of assigned technical activities relating to customer application.
• Assesses new technology and new product ideas for technical and economic feasibility, best practices and methods and latest materials.
• Designs test apparatus, equipment and develop procedures for testing products including acceptance and rejection criteria
• Builds and tests prototype devices. Selects materials for medical devices
• Provides engineering support for products launching to production and resolve issues as they arise.
• Incorporate required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the Design History File.
• Responsible for product prototyping and process troubleshooting.
• Responsible for documentation (including development of the Design History File and related records.)
• Develops project plans and timetables for assigned projects.
• Execute project plans in the development of new, existing or modified products.
• Maintain and report recommendations on new technologies, customer needs, and business developments in competitive markets.
Requirements:
• 4 year degree in Engineering-BSME or BioMedical.
• 5-10 years medical device products-engineering resins. FDA & ISO13485.
• Solid product design and product development experience with injection molding. from concept, thru design, scale up and onto production. AutoCad-SolidWorks.
• Sustaining engineering practices, product safety and root cause analysis.
• Knowledge of GMP for tooling, molding, design and process methods.
• Experience working with R&D for rapid prototyping, material selection, product design and process specs.
• LabView testing experience desired. Statistical analysis (Minitab).
• Good product/business cost knowledge and strong communication skills.
• Strong computer skills, spreadsheets, statistics and project scheduling. MS Project.
Email resume as MS Word doc attachment or call:
Mike Aquino/Technical Recruiter
MPA Associates
Cell: 330.280.3432
mpa@mpahire.com
Warning: Avoid fraudulent jobs and phishing scams, some work from home jobs and any job that asks you to pay to apply! More Info
