Sr. New Product Development Engineer - Mechanical Design
About The Position
The Sr. New Product Development Engineer will lead the design, development, and testing of components and sub-systems for existing and next-generation Endoluminal instruments, steerable catheter-based devices, and accessories that interface with a robotic system. This role is a key technical contributor and leader, handling complex design challenges, providing project leadership, and advancing solutions through product development to commercialization. The engineer will work with a technical team and outside suppliers to develop and evaluate technology solutions, establish design requirements based on customer and company needs, and prototype and refine designs. The role requires creative, efficient problem-solving in a fast-paced team environment, with strong attention to detail and product quality. It also includes setting technical direction, making design trade-offs, communicating and defending design decisions, and mentoring technicians and junior engineers.
Requirements
- Bachelor's degree in Mechanical Engineering or equivalent.
- At least 6 years of experience in a mechanical design or catheter design role.
- Proficiency using CAD to create, fabricate, and document medical-device designs.
- Experience with prototyping and fabrication methods, including 3D printing, extrusion, injection molding, machining, wire EDM, and welding.
- Ability to apply engineering first principles to understand and solve engineering problems quickly and reliably.
- Strong mechanical aptitude and visual thinking skills.
- Strong analytical and problem-solving skills using tools such as finite element analysis, statistics, and experimental designs.
- Ability to rapidly iterate prototypes and mock-ups.
- Experience applying GD&T, tolerance stack analysis, and design-for-manufacturing principles.
- Excellent written, verbal, and presentation skills, including the ability to communicate with a wide range of audiences.
- Experience collaborating with multidisciplinary internal functions and external suppliers, including quality engineering, manufacturing engineering, clinical engineering, human factors, and supplier engineering.
- Strong understanding of all phases of Design Control.
- Ability to work effectively both on a team and independently on solo assignments.
- Demonstrated follow-through and sense of urgency.
- Self-starting, hands-on, and habitually curious approach.
- Ability to handle multiple complex priorities routinely.
Nice To Haves
- Master's degree in Mechanical Engineering or equivalent.
- Experience with catheter design and manufacturing.
- Understanding of mechatronics, robotics, and servo-controlled systems.
- Experience developing requirements and performing risk assessments of candidate designs.
- Ability to remain resilient and creative and make progress amid organizational or project complexity and constraints.
Responsibilities
- Design, prototype, troubleshoot, and optimize components and subassemblies of rigid and flexible catheter structures.
- Evaluate component and subsystem designs in the context of overall system performance, reliability, manufacturability, and user experience.
- Establish technical direction, drive trade-off decisions, and influence cross-functional teams.
- Collaborate across functions to clarify clinical, usability, and business needs and translate them into design requirements.
- Develop a rigorous understanding of design risks, including why a design behaves as it does.
- Complete detailed drawings and conduct tolerance analysis using appropriate statistical best practices.
- Drive failure investigations using rigorous and efficient experimental plans.
- Prepare protocols, reports, summaries, and readouts to communicate design progress and defend or propose design decisions.
- Develop and improve test methods and assembly fixtures for building and testing prototypes.
- Collaborate with supplier engineers and manufacturing process development engineers.
- Review design changes to existing products for regulatory and manufacturing impacts.
- Mentor and guide technicians and junior engineers.
- Advance designs through the product development process to commercialization.
Benefits
- Market-competitive compensation package including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
