R&D Sustaining Engineer I — Quality, CAPA & V&V

Planet Pharma; Lafayette (CO); On-site; USD 41,000 - 47,000; Full time

Job summary

Planet Pharma is seeking a Sustaining Engineer I to research, test, and validate components and materials while sustaining current product designs. Responsibilities include DHR maintenance, determining test needs, and supporting V&V testing and design controls.

The role involves addressing quality issues, root-cause investigations, and delivering timely solutions within a regulated environment. Ideal candidates hold a BSME/BSEE or equivalent, with 0–1 year in a technical support role, capable of

Qualifications

• Experience translating technical issues into workable solutions in a manufacturing environment.
• Strong communication skills across levels and cross-functional teams.
• Knowledge of quality and regulatory requirements applicable to FDA environments.
• Demonstrated ability to manage multiple tasks with attention to detail.

Responsibilities

• Provide technical support for existing products with moderate impact and accountability.
• Lead CAPA activities, root cause analysis and investigation of complaints.
• Support design verification and validation activities and testing as needed.
• Coordinate with manufacturing on process improvements and tooling changes.
• Generate engineering change orders to sustain product lines and compliance.
• Communicate solutions clearly to clinicians and internal stakeholders.

Skills

Problem solving

Priority setting

Customer focus

Results driven

Education

BSME or BSEE, BSBM or equivalent

Job description

Planet Pharma is seeking a Sustaining Engineer I to research, test, and validate components and materials while sustaining current product designs. Responsibilities include DHR maintenance, determining test needs, and supporting V&V testing and design controls.

The role involves addressing quality issues, root-cause investigations, and delivering timely solutions within a regulated environment. Ideal candidates hold a BSME/BSEE or equivalent, with 0–1 year in a technical support role, capable of