R-D Engineer

The sustaining engineer will research, test and validate components, materials and applications while sustaining current product designs. The R&D Engineer I is responsible for the design history files, determining test requirements, V&V testing and/or coordinating V&V testing, and design controls. In addition to implementing moderate design changes that either enhance performance or address quality issues, the sustaining engineer supports/ performs complaint investigations, determines root cause failure modes and provides solutions for these product lines.

1. Provides technical support for existing products by developing solutions for problems somewhat complex in nature and/or of moderate organizational impact with a high level of accountability, moderate level of authority and some supervisory oversight.

2. Works to maintain product performance and quality for existing products by leading and assisting with issues relating to CAPAs, customer complaints and manufacturing processes, such as:

• Failure investigation and root cause analysis
• CAPA resolution
• Regulatory compliance
• Product Design Verification and Design Validation (performs V&V testing as needed)
• Design changes
• Test methods and tooling design
• Process enhancement and improvement

3. Supports research on raw materials, components and assemblies for MoC compliance (Materials of Concern, RoHS, Prop
65, etc).

4. Follows strict adherence to policies and procedures associated with an FDA controlled environment.

5. Generates Engineering Change Orders to support product sustaining efforts.

6. Works with clinician’s technical issues and communicates solutions at the appropriate level.

7. Identifies immediate solutions for short term corrections to prevent impact to business goals.

BSME or BSEE, BSBM or equivalent with manufacturing/mechanical experience and product life cycles.

0-1 year of experience working in a multifaceted environment with internal and external customers in a technical support role.

• Experience with internal and outsourced sustaining development projects
• Ability to partner cross functional organizations to successfully drive the business (relationship building skills is key – influencing – working through people)
• Solid working knowledge of quality and regulatory requirements
• Must be a strong communicator, verbal and written, across various levels of the organization as well as cross functionally
• Must be an extensive multi-tasker, and problem solver with high energy levels and strong organizational abilities. Must be organized and attentive to details.
• Good documentation practices

Problem solving, priority setting, customer focus and driving for results

AI Artificial Intelligence basic knowledge to use common tools. Agents, Flows, etc.