R-D Engineer I – Exempt

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

SUMMARY OF POSITION

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.

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, Prop65, 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.

Education

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

Experience

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

Preferred Skills/Qualifications

• 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

Skills/Competencies

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

Other Skills

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

Pay $30-34/hr