R-D ENGINEER I
Planet Pharma
Lafayette, COFresher59m agovia LinkedIn
About the Role
The R&D Engineer I is responsible for sustaining current product designs, which involves researching, testing, and validating components, materials, and applications. This role also encompasses managing design history files, determining test requirements, performing and/or coordinating verification and validation (V&V) testing, and overseeing design controls.
Key Responsibilities
- Provides technical support for existing products by developing solutions for moderately complex problems and issues with significant organizational impact.
- Maintains product performance and quality for existing products by leading and assisting with issues related to CAPAs, customer complaints, and manufacturing processes, including:
- Failure investigation and root cause analysis
- CAPA resolution
- Regulatory compliance
- Product Design Verification and Design Validation (V&V testing as needed)
- Design changes
- Test methods and tooling design
- Process enhancement and improvement
- Supports research on raw materials, components, and assemblies for MoC compliance (Materials of Concern, RoHS, Prop65, etc.).
- Generates Engineering Change Orders to support product sustaining efforts.
- Addresses clinician technical issues and communicates solutions appropriately.
- Identifies immediate, short-term solutions to prevent impact to business goals.
Requirements & Tech Stack
- 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.
- AI Artificial Intelligence basic knowledge to use common tools like Agents and Flows.
Qualifications
- Experience with internal and outsourced sustaining development projects.
- Ability to partner with cross-functional organizations to drive the business; strong relationship-building, influencing, and people-working skills are key.
- Solid working knowledge of quality and regulatory requirements.
- Strong communicator (verbal and written) across various organizational levels and cross-functionally.
- Proficient multi-tasker and problem solver with high energy levels and strong organizational abilities.
- Attentive to details.
- Good documentation practices.
Skills/Competencies
- Problem solving
- Priority setting
- Customer focus
- Driving for results