Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7 years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.

Summary: The R&D Engineer I will design and develop new products within the existing product portfolio (Cardiac Surgery, Ophthalmology and IV Therapy) as well as in new markets for Quest Medical. The R&D Engineer I will be responsible for the technical design and engineering of the products and ensure that all requirements are met. The R&D Engineer I will also be expected to participate in ongoing sustaining engineering projects and CAPA projects and provide technical support as required.

General Duties and Responsibilities:

 Product design activities including 3D modeling and electromechanical system design and prototyping.
 Design and develop electromechanical systems to support product development efforts, including automated or semi-automated test and assembly fixturing.
 Generate technical drawings, data sheets, and schematics.
 Work with senior engineers and Manager to quickly solve technical issues and resolve problems/delays associated with projects.
 Design for manufacturing activities including final part/assembly design, manufacturing process design, manufacturing assembly procedures and manufacturing testing procedures.
 Participates 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.
 Select and develop appropriate test tools, applying the latest techniques in testing and verification e.g., data-driven testing and clinical simulations.
 Participate in project design reviews with emphasis on gap/risk analysis to ensure projects meet predetermined goals and objectives.
 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.
 Participate in the Change Control process to identify the quality implications and impact of proposed changes to product performance via the testing process.
 Assist the Manager in preparing project plans, budgets, and schedules.
 Provide technical guidance to technicians, interns, and cross-functional team members assigned to product and process activity relating design, testing, and documentation.
 Work with team to address daily issues associated with GMP, safety and enhancing testing infrastructure at Quest.

Qualifications:

 Bachelor of Science in a technical field such as electrical engineering, mechanical engineering, mechatronics engineering, or other related engineering field is required.
 1-3 years of experience in design and development of products. Applicants with an advanced degree in the above fields may be considered with less experience.
 >1 year of experience in electromechanical systems design, including design and implementation of systems with 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.
 Knowledge/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.
 Computer literate and ability to use major software tools including proficiency with CAD programs (SolidWorks preferred).
 Knowledge of statistical techniques.
 Must demonstrate initiative and require minimal supervision. Self-starter with results driven characteristics.
 Ability to communicate effectively.
 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.
 Project management experience and knowledge of design controls processes and QSR.
 Detail oriented and ability to organize large amounts of data. This includes the need for good documentation practices.
 General knowledge of good laboratory practices, common laboratory equipment and hazards, upkeep and handling of biologic mediums preferred.
 Experience in the medical device industry or in a regulated industry preferred.