R&D_Engineer II/III

Summary:

The R&D Engineer II/III will design and develop new products within the existing product portfolio (Cardiac Surgery, Ophthalmology and IV Therapy) as well as new markets for Quest Medical.  The R&D Engineer II/III will be the project leader for these products and will be expected to lead a cross-functional team to ensure all phases of the design controls process are delivered within project timelines and budgets.  The R&D Engineer II/III will also be responsible for the technical design and engineering of the products ensuring that all requirements are met.  Additionally, this individual will be expected to participate in ongoing sustaining engineering projects and CAPA projects to provide technical support, as required.

General Duties and Responsibilities:

• Product design activities including 3D modeling and rapid prototyping of individual components, assemblies, and electromechanical systems.
• Design and develop electromechanical systems to support product development efforts, including automated or semi-automated test and assembly fixturing.
• Generate technical drawings, datasheets, and schematics.
• Solve technical issues and resolve problems/delays associated with projects with a high degree of independence.
• Lead design for manufacturing activities including final part/assembly design, manufacturing process design, manufacturing assembly procedures and manufacturing testing procedures.
• Participate in the safety hazard/risk analysis on products/systems, collaborating with the risk manager and other engineering disciplines.
• Perform design verification and validation activities which meet all necessary requirements of a project, including drafting qualification documents ranging from equipment qualification to product validation.
• Understand and execute all aspects of design controls during product and/or process development projects.
• Understand quality system requirements of customers, FDA, QSR, and other regulatory agencies, and use quality tools to improve processes and products within those standards.
• Design and implement test and simulation instrumentation, equipment, and procedures.
• Support collaborative ideation through concept development, prototyping, and feasibility studies.
• Assist in the development of customer and product requirements and specifications.
• Cultivate understanding of relevant clinical needs, product opportunities, and technology.
• Support marketing and clinical assessment of new products and concept initiatives.  Help define unmet needs and clinical pathway to address device opportunities. 
• Analyze the competitive landscape, customer and market trends, and product requirements as part of new product development processes. 
• Advise and assist in the application of instrumentation in clinical environments to support existing product lines and new product development.
• Select and develop appropriate test tools, applying the latest techniques in testing and verification e.g., data-driven testing and clinical simulations.
• Participate in the change control process to identify the quality implications and impact of proposed changes to product performance via the testing process.
• Coordinate and lead project design reviews with emphasis on gap/risk analysis to ensure projects meet predetermined goals and objectives.
• Assist in preparing project plans, budgets, and schedules.
• Provide technical guidance to junior engineers, technicians, interns, and cross-functional team members assigned to product and process activity relating design, testing, and documentation.
• Proactively address and work with team on daily issues associated with GMP, safety and enhancing testing infrastructure at Quest.

Qualifications:

• Bachelor of Science degree in a technical field such as mechanical engineering, electrical engineering, mechatronics engineering, automation engineering, or other related engineering field is required.
• 2-5 years of experience in design and development of products with project management experience. 
• Knowledge of/experience with common manufacturing/fabrication processes including, but not limited to, injection molding, sheet metal, extrusion, solvent bonding, ultrasonic welding, RF forming/welding, thermoforming, pad printing, and  other relevant medical device processes.
• Strong working knowledge of electromechanical systems, including design and implementation of systems including off-the-shelf electromechanical components, single-board microcontrollers and computers, custom PCBs, and/or PLC-based systems. Experience with relevant programming languages required.
• Skill in mechanical component, part, and assembly design and fabrication. 
• Project management experience and knowledge of design controls processes and QSR.
• Ability to communicate effectively at all levels of personnel.
• Computer literate and ability to use major software tools including proficiency with CAD programs (SolidWorks preferred).
• Knowledge of statistical techniques. 
• Possess above average technical writing, analytical, and communication skills. Ability to communicate complex problems for understanding to non-technical personnel. Ability to effectively communicate with clinicians and health professionals in the field. 
• Results-driven self-starter.
• Detail oriented with ability to organize large amounts of data.  Knowledge of good documentation processes.
• General knowledge of good laboratory practices, common laboratory equipment and hazards, and upkeep and handling of biologic mediums preferred.
• Experience in the medical device industry or in a regulated industry preferred.