Job Description

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 II 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 II must collaborate with members of various departments and internal customers throughout the course of project work.

Job Details

Provide cross-functional leadership as a core team member and provide oversight to the technical team. 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.

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:

• Support collection of Voice of Customer (VOC) data and/or clinical feedback
• Lead activities to ensure product is clinically acceptable by coordinating Human Factors Engineering/Usability and clinical testing activities.
• Perform engineering analysis (Mechanical, Electrical, Software, Hardware, Usability, 3D modeling, etc.) and develop design control documentation.
• 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).

1. Test and Evaluation: Design and execute testing (DOEs, Design Verification/Validation, animal/bench testing, etc.)
2. 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)
3. Supplier management: Identify and evaluate suppliers, negotiate and develop specifications and inspections, and support procurement.
4. Support Manufacturing Engineering: Support equipment procurement, equipment and process development and validation, and prototype builds
5. Supervision: May be required to supervise, lead, or train Engineers, Assemblers and Technicians in the project group.
6. 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.
7. 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.
8. Intellectual Property: Ensures technical activities are properly documented in lab notebook. Participates in and contributes to technical discussion sessions to generate new intellectual property.
9. 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.
10. Other Duties: As assigned

Knowledge, Skills and Abilities (KSAs)

• Demonstrated ability to design, specify, assemble and validate manufacturing equipment and processes.
• Demonstrated ability in the use of critical thinking, problem solving and analysis.
• Working knowledge of Statistical Process Control (SPC), Six Sigma principals and problem solving and decision-making tools.
• Effective communication skills, both verbal and written.Strong communications skills. Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to US and notified bodies.
• Knowledge working under quality systems designed to meet governmental regulations such as 21 CFR 820, and PMDA MO. 169, ISO 13485 and ISO 14971 and additional knowledge of EU MDR 2017/745 is a plus.
• Background Experiences
• BS in Mechanical, Electrical, or similar engineering discipline from an accredited university or college with 12 or more years of working experience with increasing responsibility in Manufacturing and Process Development in the medical device field advanced degree in Engineering preferred
• Career progression of increasing responsibility and experience in Manufacturing Engineering, Process Development, and/or Automation Engineering.
• Experience in an FDA regulated industry, medical device or pharmaceutical preferred
• Experience in a manufacturing environment for designing, specifying, assembling, and validating manufacturing equipment and processes.
• Hands-on experience with manufacturing equipment ranging from manual to fully automated preferred.
• Experience working with Design control procedures and requirements, including risk management.
• Effective use of MS Office Suite.

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-solving and troubleshooting skills for solving design and process issues and implementing solutions during product development.

Ability to apply Design for Manufacturability/Assembly (DFM, DFA) and Design for Six Sigma design control principles and tools.

Understanding of the application and interpretation of statistics (e.g. DOE, hypothesis test, sample sizes, etc.)

General knowledge of computer aided design, specifically solid modeling. Ability to create component/fixture CAD models/drawings demonstrating understanding of proper machining/molding tolerances.

Utilize metrology tools to perform basic and advanced measurements.

Ability to distill complex technical information and explain to a less technical audience; ability to create and deliver technical presentations to engineering personnel and executive management.

Ability to support development of Gantt charts and manage work schedules for small project or segment of larger project.

Understanding of the cross-functional interactions needed for the development of new products within FDA design control guidelines.

Application of computer skills including MS Office Suite, Minitab, Project, Visio, etc.

Background Experiences

• Bachelor’s degree in Engineering or related discipline, Master’s degree preferred, and a minimum of 12 years relevant experience required, or equivalent combination of education, training, and experience.
• Experience in the medical device industry preferred.
• Design verification and validation experience required.
• Test method validation experience required.
• Process validation experience: experience in validating product manufacturing processes to FDA compliance preferred.
• Experience with Design Control procedures and requirements, including risk management required.
• Experience with catheter manufacturing and assembly methods preferred.

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