Senior Product Development Engineer
2 days ago
Cypress HCM is seeking a highly skilled Senior Product Development Engineer to lead the development of medical device concepts, prototypes, processes, and products from initial design to release. This is a contract role, 100% onsite in Maple Grove, Minnesota.
Key Responsibilities- Lead smaller projects with clear execution paths and deliverables.
- Assist in writing proposals for existing clients to achieve new deliverables.
- Design and implement new methodologies, materials, machines, processes, or products to bring concepts to market.
- Maintain detailed documentation throughout all phases of research and development.
- Prepare project plans for basic projects, specifying project phases, tasks, task interdependencies, durations, resource assignments, and costs.
- Conduct and participate in meetings directly with clients.
- Proactively communicate with the team to ensure a two-way exchange of information.
- Conduct risk analysis for products under development.
- Coordinate activities with outside suppliers and consultants to ensure timely delivery of supplies or services.
- Mentor junior engineers on technical development and project management as required.
- Lead brainstorming sessions and design reviews.
- Generate innovative concepts for new medical device designs to satisfy clinical requirements and meet or exceed customer expectations.
- Participate in the organization and execution of interdepartmental activities to ensure project completion on schedule and within budget constraints.
- Conduct feasibility studies of the design to determine its ability to function as intended.
- Ability to generate and execute protocols and reports as needed to support validation activities, including Design Verification, IQ, OQ, PQ.
- Maintain standards of excellence in all Product Development processes.
- Bachelor's degree in Mechanical or Biomedical Engineering.
- 8-10 years of medical device design and development experience.
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- SolidWorks 3D CAD proficiency.
- Knowledge of probability and statistics.
- Experience in design for catheters and extrusions.
- Experience in design for reinforced shaft, delivery systems, and steerable catheters.
- Depth of knowledge in one or more technical areas, for example laser/resistance welding.
- Demonstrated ability to bring products from concept to market.
- Ability to interact with clients and companies in a professional manner.
- Customer focus with excellent communication skills, written and oral.
$45-65 per hour, depending on experience level.
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