Engineer, Combination Product Medical Devices - (JP14307)

• Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments.
• Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes).
• Analyze and report data, along with any recommendations, to a variety of stakeholders.
• Provide technical input for mechanical problems to programs as needed.
• Plan and execute tolerance and robustness analysis of complex mechanical designs.
• Use project planning to monitor and track project deliverables to ensure accurate completion.
• Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle.
• As part of the team working on device platforms, ensure alignment of documentation to support variants and combination products.

• Strong written and oral communication skills
• Able to execute lab test, which includes safe and proper operation of lab equipment
• Experience in drug/device combination product design, and development

• Planning and executing testing, Coordinate material hand-offs, Authoring, reviewing and approving documents, attending and participating in the team meetings (as needed)

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• B.S. in Engineering or Scientific Discipline
• Effective Communicator (Oral/Written)
• Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

• Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts
• Experience in drug/device combination product design, and development
• Background in development, commercialization, and lifecycle management of medical devices
• Physical test method development, qualification, and validation
• Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, manual and automated autoinjector testing, CT scanner etc.)
• Experience conceptualizing, designing, and building test fixtures
• Technical understanding of drawings including tolerance stacks and robustness analysis
• Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
• Familiarity with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601)
• Knowledge of dFMEA/pFMEA
• Capable of working on multiple projects in a deadline driven environment
• Strong oral and written communication skills, decision making, presentation, and organization skills
• Ability to collaborate with other disclines within the technical team such as, systems engineering, design engineering, human factors, MSAT, packaging engineering and other functions e.g., drug product, drug substance and product quality.
• Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach
• Track record of building or participating as a member of successful teams
• Working knowledge of MS Office tools, Solidworks, Minitab or JMP and Smartsheet

• Gaining combination product development experience and a better sense of device performance.
• Will gain auto injector experience

Salary : $36 - $41