R-D Engineer - Exempt

Position: R-D Engineer I - Exempt
SUMMARY OF POSITION:
Within the Airways R&D sustaining engineering group, the sustaining engineer's primary responsibility will be to support Airways disposable medical devices currently on the market The sustaining engineer will research, test and validate components, materials and applications while sustaining current product designs This position 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
Support implementation of eIFU's (Electronic IFU) Program.

ESSENTIAL FUNCTIONS:

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), eIFU's (Electronic IFU) Program.

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

5 Generates Engineering Change Orders to support product sustaining efforts.

DEPARTMENT SPECIFIC/NON
- ESSENTIAL FUNCTIONS:

1 Prepares analysis reports for managers, project leaders or other personnel.

2 Presents progress status to management and teams, as required.

3 Develops and tracks work schedule and assignments.

4 Provides input to departmental planning and resource activities.

5 Other duties as assigned with or without accommodation.

• Perform Design verification testing in Laboratory environment.

• Update Product Design documentations in moderated changes such as Design History files, V&V testing report and protocols, Product Requirement documents adhering to design controls.

• Makes minor changes in systems and processes to address Quality issues.

Requirement:

MINIMUM REQUIREMENTS:

Education:

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

Experience:

0-2 years of experience working in a multifaceted environment with internal and external customers in a technical support role.

Top 3 technical skills that are required for the role:
1 Knowledge of Design Verification testing and its documentation.
2 Knowledge of Quality, Regulatory requirements, Proficiency in Excel & Word applications.
3 CAD - Solidworks

Preferred Skills/

Qualifications:

• Demonstrated experience and a proven track record of success in product support evidenced by lowered support costs and by a failure rate reduction

• Experience with internal and outsourced sustaining development projects

• Proven 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.

• Medical Device and clinical environment experience

• Sustaining engineering MoC programs, product design and project management experience.

• CAD - Solidworks proficiency (3d models and 2d drawings)

• MS Teams proficiency

• Good documentation practices

Skills/

Competencies:

Problem solving, priority setting, customer focus and driving for results
Minimum 4…