The System Engineer is responsible for design, development and technical problem solving of specific product/s in accordance the Quality System and customer requirements. This position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects. The System Engineer may serve as a key interface between engineering teams, both internal and external. The System Engineer may guide development acceleration of our embedded system by leading external partners (OEM Medical Alliance, Mechanical, Electrical, Software engineering) and roadmaps for projects. The System Engineer will be responsible for ensuring the completeness and quality of the associated design controls and documentation for Hardware (HW), Software (SW) and Mechanical components of the system. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing. Participates in and/or conduct animal and bench top study projects. This position may work directly with customers.
1. Project Engineering: Lead development acceleration of our embedded system by leading external partners (OEM Medical Alliance, Mechanical, Electrical, Software engineering) and roadmaps for projects as a key interface between engineering teams, both internal and external. This may include feasibility studies, designing & implementing evaluations and providing technical input for justification of project and design. As part of a project team, or on an individual basis a. Contribute to develop detailed specifications, construction of prototypes, pre-clinical trials for new products. b. Manage requirements, interface specifications, systems models and tests relative to development milestones and help define and refine Systems Engineering & Design Control processes and practices c. Work closely with engineering teams to plan / de-risk remaining development work, taking into account key interactions and interfaces d. Serve as key interface point with external development partners e. Contribute to design and define product testing plans and protocols. Perform testing, analyze results, suggest recommendations and/or conclusions and document clearly and completely in technical reports. These reports could be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims f. Research and recommend vendor and material choices for product. g. Prepare & lead technical design reviews to a cross-functional and technical team. h. Contribute to the DHF and regulatory submittals providing training to ensure proper design transfer. i. Prepare and present product designs, production processes and related activities to Engineering team and/or upper management. j. Ensure that product documentation is in accordance with Quality System requirements design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control and design control requirements.
2. Project Management:
Contribute multi-functional project team activities from early project conceptualization through clinical testing and regulatory submissions. a. Maintain and manage activities towards the overall project schedule, and ensure that critical timelines are established and met. b. Perform as a Technical Lead on a project to lead and implement the technical aspects involving coordination with other departments. c. Conduct regular project team meetings to ensure communication between multi-functional team members. d. Develop positive proactive working relationships with team members and other staff.
3. Regulatory Compliance:
Provide engineering testing and documentation that is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies. Support regulatory submissions by collaborating with regulatory affairs representative and providing technical support and response to the agencies.
4. Customer Interface:
May work directly with the customer representatives, Marketing and Sales staff, to determine needs in product design, user interface, and possible integration of product with other medical systems or products. May provide user training and contribute to the development of support materials as required. May work with physicians and observe clinical cases to obtain input on product designs and enhancements.
5. Product Enhancements:
Contribute to design prototypes and product modifications in response to pre-clinical trials and customer feedback. Research, design and develop new products enhancements in accordance with Quality System requirements.
Ensure that new products are designed to facilitate manufacturability. May be required to lead or contribute to the process of transferring product from development to manufacturing.
May be required to supervise, lead or train Engineers, Assemblers and Technicians in the project group.
8. Responsibilities to the Quality System: a. Support the Quality System and Quality Policy. b. Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities. c. Ensure staff are trained in applicable procedures prior to performing Quality- related activities. d. Inform responsible personnel of concerns involving product quality.
9. Intellectual Property:
Ensure technical activities are properly documented in lab notebook. Participate in and contribute to technical discussion sessions to generate new intellectual property.
Perform job functions in a safe and effective manner. Ensure that employees under position supervision are adhering to the safety procedures of the company.
11. 0ther Duties: As assigned.
(Knowledge, Skills and Abilities)
? Broad Knowledge across mechanical, electrical and software engineering, as part of combined HW/SW systems
? Deep knowledge in at least one discipline, including electrical, mechanical or software engineering
? Solid background in Systems Engineering processes
? Ability to lead the design and development of a new or novel medical device on a bench top or pilot line scale.
? Demonstrated successful execution of product design, development and documentation.
? Experience with Design Control procedures and requirements
? Strong communications skills to understand and explain complex engineering problems to non-engineering personnel. Ability to create and deliver presentations to executive management. Ability to create detailed Technical Reports appropriate to send to the FDA. Ability to create to SOP’s.
? Ability to create product design and development strategies
? Strong decision making skills. Ability to perform comparative analysis on alternate product designs, component sources, process methods, or test methods and make a recommendation.
? Ability to appropriately document new or modified product designs to be contained in DHF’s or regulatory filings, or in-house engineering. Ability to create a material specification for any component procured from an outside source.
? Ability to define, write and perform DOE’s and test protocols for evaluating prototype performance to design criteria.
? Strong troubleshooting skills for solving process and design issues during product development.
? Demonstrated ability to distill complex technical information and explain to a much less technical audience.
? Ability to evaluate component suppliers for capability to provide development and production parts or services.
? Ability to create and work from engineering drawings and/or specs of products, components
? Skilled in the use of CAD software such as Auto cad, Solid works, Pro E
? Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MOD.
? Familiarity with mechanical/electronic/chemical equipment and tools in laboratory testing. Practical knowledge of statistical techniques/methods. Knowledge of prototype build methods.
? Ability to travel to observe clinical cases, attend trade shows, attend training activities, and visit suppliers, etc. will be required periodically.
? Demonstrated strong technical writing, validation, SOP and presentation skills. (written communication)
? Background in Embedded electronics preferred.
? Experience integrating a small motor into a medical device preferred
? Experience Verification and Validation
? Knowledge of anatomy & physiology, clinical use of medical products preferred.
? Bachelor’s degree in Engineering or related discipline or equivalent experience in the medical device industry.
? BS +7 years or MS +5 years or PhD +3 years previous experience in software, mechanical, electrical or in other related technical area including internships and coop positions; experience in the medical device industry preferred.
? Demonstrated experience in implementing technical strategy for a medical device project and coordinate with applicable cross-functional leaders to gain alignment.
? Experience with contributing to strategies for product design and development based on customer needs and Design Input. Demonstrated design and comparative analysis skills.
? Experience with performing comparative analyses on alternate product designs, component sources, process methods, or test methods and make a recommendation.
? Experience in presenting and explaining to upper/executive management.
? Previous Project Management experience a plus.
? Experience with catheter manufacturing and assembly methods preferred.