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Sr. Product Development Engineer
2 months ago
A Minnesota based medical device client is looking to hire engineering talent onsite at their new facility in Maple Grove. This product development engineer will act as a leader on the engineering team as they work to develop complex catheter devices from concept and ideation through commercialization. We are looking for strong process development focused minds that have experience with root cause analysis, are comfortable juggling multiple priorities at once and have strong engineering fundamentals overall. This person will be interacting with clients so someone who is comfortable in that capacity is key as well.
Responsibilities:
- Oversees development of concepts, prototypes, and products from initial design to release.
- Leads smaller projects with a clear execution path, ensuring deliverables are met.
- Assists in creating proposals to secure new deliverables within ongoing efforts.
- Designs and implements methodologies, materials, and processes to bring concepts to market, including essential documentation.
- Maintains comprehensive documentation throughout R&D phases.
- Prepares project plans detailing phases, tasks, dependencies, resources, and costs.
- Conducts client meetings and proactively communicates with the team for continuous information flow.
- Performs risk analysis for developing products.
- Coordinates with external suppliers and consultants to meet timelines.
- Mentors junior engineers in technical development and project management.
- Leads brainstorming sessions and design reviews.
- Develops innovative concepts for medical device designs to meet clinical and customer needs.
- Supports interdepartmental activities to ensure projects are on schedule and within budget.
- Conducts feasibility studies to ensure design functionality.
Qualifications:
- Bachelor's degree in Mechanical or Biomedical Engineering is preferred.
- 10+ years of experience in medical device design and development is required.
- Familiarity with FDA QSR and ISO 13485 regulations.
- Proficiency in SolidWorks 3D CAD.
- Knowledge of probability and statistics.
- Experience in catheter and extrusion design is essential.
- Expertise in reinforced shaft, delivery systems, and steerable catheter design is required.
- In-depth knowledge in technical areas like laser/resistance welding.
- Proven track record of bringing products from concept to market.
Pay Rate - $40-60/hr
