Summary:
A leading contract manufacturing firm based in Minneapolis, MN, is in search of a Senior Product Development Engineer. This role is focused on leading the development of catheter concepts from initial design to market release.
The company, known for its innovative approach to complex catheter product development, is specifically seeking candidates with the following qualifications:
Responsibilities:
- Spearhead the development of concepts, prototypes, processes, and products from initial design to market release.
- Take charge of smaller projects with clear execution paths, ensuring deliverables are met.
- Assist in crafting proposals for existing clients to meet new deliverables within ongoing projects.
- Innovate methodologies, materials, machines, processes, or products to usher concepts to market fruition, meticulously documenting product and process details.
- Maintain meticulous documentation throughout all research and development stages.
- Draft project plans outlining phases, tasks, durations, resources, and costs for basic projects.
- Engage in direct client meetings and maintain proactive communication within the team.
- Conduct risk analyses for products in development.
- Coordinate with external suppliers and consultants to ensure timely delivery of required supplies or services.
- Mentor junior engineers on technical growth and project management as needed.
- Lead brainstorming sessions and design reviews.
- Generate creative concepts for new medical device designs, meeting clinical requirements and surpassing customer expectations.
- Organize and execute interdepartmental activities to ensure projects are completed on schedule and within budget.
- Conduct feasibility studies to assess design functionality.
- Generate and execute protocols and reports to support validation activities, including Design Verification, IQ, OQ, PQ.
- Uphold standards of excellence in all Product Development processes.
- Fulfill any other assigned duties.
Position Requirements:
Education, Experience, Skills:
- Bachelor's degree in Mechanical or Biomedical Engineering preferred; equivalent experience may be considered.
- Minimum of 10 years of experience in medical device design and development.
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- Proficiency in SolidWorks 3D CAD.
- Knowledge of probability and statistics.
- Experience in catheter and extrusion design.
- Expertise in reinforced shaft, delivery systems, and steerable catheters design.
- Profound knowledge in technical areas such as laser/resistance welding.
- Proven ability to shepherd products from concept to market.
- Strong interpersonal skills for client interaction, coupled with excellent written and verbal communication skills.
