R-D Engineer I - Exempt

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

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

• 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.
• 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
• Supports research on raw materials, components and assemblies for MoC compliance (Materials of Concern, RoHS, Prop65, etc).
• Follows strict adherence to policies and procedures associated with an FDA controlled environment.
• Generates Engineering Change Orders to support product sustaining efforts.
• Works with clinician’s technical issues and communicates solutions at the appropriate level.
• 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