We are seeking a Senior Principal Delivery System Engineer to play a key role on the next generation EVOQUE transcatheter tricuspid valve replacement team. In this role, you will serve as a lumen and subsystem owner, responsible for advancing critical catheter subassemblies from early concept through design freeze and into later phases supporting commercial launch. You will collaborate closely with a dedicated team of R&D engineers and cross-functional partners to bring the next generation EVOQUE platform to market; contributing directly to a transformative therapy aimed at improving outcomes for patients with tricuspid valve disease.
- Contribute to the development of a next-generation transcatheter tricuspid valve replacement system by applying clinical insights and learnings from previous device generations to advance the design and address unmet patient and user needs.
- Initiate and lead in the improvement, design and optimization of highly complex tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products
- Lead concept development and prototype iteration internally and with external vendors, applying data-driven evaluation and clearly communicating findings and recommendations.
- Own and manage the design and budget of catheter and lumen subsystems from concept selection through design freeze and into verification and validation.
- Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems by balancing mechanical performance targets (e.g., tensile strength, flexibility, profile) with clinical performance needs (e.g., echogenicity, stability) and manufacturability requirements.
- Work closely with cross-functional teams in pre-clinical and clinical environments to guide design decisions informed by cardiovascular anatomy, heart structure, and valve pathology.
- Generate work instructions, IP, engineering models, and drawings; coordinate prototype builds; and develop project plans to establish/characterize product and/or process specifications and assess complex technology.
- Maintain accurate documentation of concepts, designs, drawings, and procedures.
- May lead cross functional teams through complex design control activities including requirement specs, and risk documents with substantial knowledge on design control requirements
- Oversee R&D support activities; coordinate technician/engineer work; provide direction on prototyping and testing; and train technicians/engineers while providing constructive feedback.
- Interface with Clinical Development, Manufacturing, Quality, Marketing, and vendors/suppliers to ensure compliance with internal policies and procedures, FDA regulations, and ISO standards.
- Provide direction and guidance on strategies related to technical solution areas
What you'll need (Required):- Bachelor's Degree in Engineering or Scientific field with a minimum of 8 years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with a minimum of 7 years of experience -OR- Ph.D. or equivalent in Engineering or Scientific field with a minimum of 4 years of experience
- Direct experience designing and building catheter-based delivery systems
- Proficiency with Creo/ProE or SolidWorks
What else we look for (Preferred):- Proficiency in the usage of relevant computer software including SolidWorks
- Hands-on experience designing and manufacturing interventional catheters of various types (e.g. steerable catheters, sheaths, echogenic catheters, internal lumens, etc. consisting of polymers, metals, braids, coils, cables, wires, radiopaque markers, laser cut hypo tubes, multi-lumen extrusions, etc.).
- Demonstrated track record of effective, efficient collaboration with vendors and internal development partners or supporting organizations including: extrusions, polymers, textiles, catheters, and metals processing.
- Experience with various polymer components used for catheter construction including liner, jacket, tie layer, and heat shrink used in reflow and tipping operations with braided, coiled, or laser cut tube shafts.
- Experience supporting interventional procedures in a clinical setting (physician training, device prep, procedure planning, device proctoring, etc.)
- Experience with laser cutting/welding
- Experience with machining and injection molding
- Able to evaluate how a part or sub-assembly integrates with, impacts, and is impacted by the broader system around it.
- Able to manage conflicting design priorities with composure and creativity, finding balanced solutions or innovative ways to meet multiple needs.
- Must demonstrate a proven strength in applying relevant knowledge and judgment as a creative innovator, strategic problem solver, and technical leader.
- Must be passionate, highly collaborative, and willing to engage in productive, creative debate with expert knowledge and understanding of relevant engineering principles and theories.
- Must be highly motivated, driven, and able to tackle challenging technical problems independently with minimal supervision and strict attention to detail.
- Must be disciplined and organized to effectively plan, execute, document, analyze, and communicate professionally with all organizational levels learnings and design development progress.
- Must have a strong hands-on mechanical aptitude and flexibility to work in a dynamic environment.
- Must have excellent interpersonal relationship skills including negotiating and relationship management skills, effective verbal and written communication, listening, and diagnostic skills. The ability to collaborate effectively and gain support from cross-functional teams and stakeholders is key to successfully delivering results.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
