Sustaining R&D Engineer I — Quality & Root-Cause

Planet Pharma; Lafayette (CO); On-site; USD 85,962,000 - 97,424,000; Full time

Benefits offered by this job

Pay: $30-34/hr

Job summary

Planet Pharma sustains existing products by researching, testing and validating components and materials while supporting current designs. The R&D Engineer I handles design history files, V&V testing coordination, and design controls to implement moderate changes addressing quality issues.

Key tasks include CAPA handling, root cause analysis, and regulatory compliance in an FDA-regulated setting. Strong communication, documentation and cross-functional collaboration are essential.

Qualifications

• Must have strong communication across levels and cross functional teams.
• Experience with sustaining development projects is preferred.
• Solid knowledge of quality and regulatory requirements.
• Ability to influence and partner across organizations.
• Excellent multitasking and organizational abilities with good documentation.

Responsibilities

• Provides technical support for existing products with a high level of accountability.
• Leads issues related to CAPAs, customer complaints and manufacturing processes.
• Performs failure investigations and root cause analyses.
• Supports MoC compliance and regulatory requirements (RoHS, Prop65, etc.).
• Generates Engineering Change Orders for sustaining efforts.
• Collaborates with clinicians to resolve technical issues and communicate solutions.
• Identifies short-term corrective actions to protect business goals.

Skills

Problem solving

Priority setting

Customer focus

Driving for results

Education

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

Tools

AI basics

Agents

Flows

Job description

Planet Pharma sustains existing products by researching, testing and validating components and materials while supporting current designs. The R&D Engineer I handles design history files, V&V testing coordination, and design controls to implement moderate changes addressing quality issues.

Key tasks include CAPA handling, root cause analysis, and regulatory compliance in an FDA-regulated setting. Strong communication, documentation and cross-functional collaboration are essential.