Sr. R&D Engineer

Job Summary

This is an advanced intermediate level individual contributor position and hands on role in which the assigned associate will work independently on complex tasks and lead/manage extended teams to complete complex technical work under guidance by more senior engineering leads or engineering managers. The Senior R&D Engineer 1 may represent R&D in a complex multi-discipline product development project or multiple smaller projects, and is capable of identifying technical risk, challenging design decisions, and bridging the gap between the functional elements of the product development process. The position may include (but is not limited to) responsibility for the following areas: defining user needs and required functionality early in the development cycle, ensuring completeness and quality of associated design controls and documentation, leading human factors/usability activities, component/material sourcing, design verification and validation, project engineering, process development, and technology transfer in accordance with the company’s Quality System and customer requirements. The Senior R&D Engineer 1 must collaborate with members of various departments and internal customers throughout the course of project work.

Job Details

1. Provide cross-functional leadership as a core team member and provide oversight to the technical team.
2. Participate as an extended team member of a collaborative and cross-functional team, plan expenditures, attend business meetings and prepare minutes, presentations, communications, and reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders.
3. Provide and implement ideas, methods, or processes for performance improvement.
4. Support the design and development of new products:
   1. Support collection of Voice of Customer (VOC) data and/or clinical feedback
   2. Lead activities to ensure product is clinically acceptable by coordinating Human Factors Engineering/Usability and clinical testing activities.
   3. Perform engineering analysis (Mechanical, Electrical, Software, Hardware, Usability, 3D modeling, etc.) and develop design control documentation.
   4. System integration: Manage system integration so device features (such as hardware, software, and mechanical systems) interface well internally (between subsystems) and externally (with other devices used in the same procedure).
5. Test and Evaluation: Design and execute testing (DOEs, Design Verification/Validation, animal/bench testing, etc.)
6. Risk Management: Analyze use, design, and/or process risk and develop risk control and risk mitigation documentation (harms list, hazard analysis, failure mode effect analyses FMEAs)
7. Supplier management: Identify and evaluate suppliers, negotiate and develop specifications and inspections, and support procurement.
8. Support Manufacturing Engineering: Support equipment procurement, equipment and process development and validation, and prototype builds
9. Supervision: May be required to supervise, lead, or train Engineers, Assemblers and Technicians in the project group.
10. Regulatory Compliance:  Provide engineering testing and manufacturing documentation that is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies such as FDA QSR (21 CFR Part 820), ISO13485, ISO 14971, 21 CFR 803 and 804 (MDR regulations), Japan PMDA MO. 169, EU MDR, and all other applicable regulations.
11. Responsibilities to the Quality System: Support the Quality System and Quality Policy. Be aware of and contribute to improvement changes in Quality System standard operating procedures (SOPs) and requirements including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality.
12. Intellectual Property:  Ensures technical activities are properly documented in lab notebook. Participates in and contributes to technical discussion sessions to generate new intellectual property.
13. Safety: Perform all activities and documentation related to employee health and safety and ensure compliance with all legal and regulatory requirements. Performs job functions in a safe and effective manner. Ensures that employees under position supervision are adhering to the safety procedures of the company.
14. Other Duties: As assigned

Functional Requirements - Knowledge, Skills, and Abilities

• Good knowledge of key regulations/standards for medical product manufacturing and development: 21 CFR 820 (Quality System Regulation), 21 CFR 803 and 804 (MDR regulations), ISO 13485, ISO 14971, PMDA MO. 169. Additional knowledge of EU MDR 2017/745 is preferred.

• Demonstrated analytical, logical problem-