Are you an experienced R&D Engineer with a desire to excel? If so, then Talent Software Services may have the job for you. Our client is seeking an experienced R&D Engineer to work at their company in Maple Grove, MN.
Position Summary: Position will not be working on new product development; rather, sustaining engineering. The client is seeking a highly motivated mechanical engineer to work in a biotechnology company. This R&D Engineer III will be an extended team member in sustaining engineering for a strategic product in our Interventional Oncology and Embolization business. This role will involve complex technology and the ability to be at the forefront of research and development for our customer-centered approach to serve cancer patients. The Sustaining Engineer is responsible for maintaining and improving existing products, processes, and systems to ensure ongoing quality, reliability, compliance, and cost-effectiveness. This role bridges engineering and manufacturing, supporting cross-functional teams to resolve technical issues, implement design changes, and improve product lifecycle performance.
Primary Responsibilities/Accountabilities:
- Provide engineering support for existing PI EME systems, including troubleshooting, root cause analysis, and corrective/preventive actions (CAPA).
- Lead and implement engineering change orders (ECOs), design updates, or component substitutions.
- Collaborate with manufacturing, quality, supply chain, and regulatory teams to address non-conformances, process improvements, and product updates.
- Support validation and verification activities (V&V) for design or process changes.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Designs and coordinates standard engineering tests and experiments.
- Designs, procures, and fabricates tooling and fixtures.
- Summarizes, analyzes, and draws conclusions from test results.
- Prepares standard reports/documentation to communicate results to the technical community.
- May train and/or provide work direction to technicians.
- Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
- Build Quality into all aspects of their work by maintaining compliance with all quality requirements.
Qualifications:
- Degree in Engineering - mechanical is preferred, and will be moved to the top of the list.
- BS Degree with 3-4+ years' experience
- If an MS degree in engineering, 2+ years of experience
- Medical device design and or process experience preferred.
- Desire for leadership with traits of being an independent thinker, self-starting, and with strong communication skills.
- Strong mechanical aptitude with a creative, unbiased approach to problem solving.
- Proficient in SolidWorks