This position is responsible for the technical leadership of the RapidPulse products. The role oversees technical project needs such as finalizing the system design for commercialization, resolving technical design challenges, collaborating and overseeing critical suppliers, and conducting the overall design verification and validation activities. Experience with Design for Manufacturing to ensure the system will smoothly transition into a commercial product is critical.
- Develop a deep understanding of the technology, including electromechanical systems and disposable sub-systems.
- Drive product design efforts locally and at suppliers.
- Solve technical challenges.
- Create, review, and approve prototype and production product designs.
- Develop and implement product-related test methods and participate in design verification and validation activities.
- Ensure system design is easy to manufacture to ensure the system will smoothly transition into a commercial product.
- Lead the Product Development design control activities to allow RapidPulse to meet established business goals.
- Interface with internal and external customers including Clinical/Regulatory and leading Physicians to define and clearly document product specifications for new products.
- Interface with external suppliers and customers who are jointly involved in product development.
- Ensure all design control documentation is incorporated and accessible in RapidPulse Design History File.
- Execute the design control process for specified new RapidPulse products in compliance with both CFR Part 21 and ISO 13485
- Ensure that documentation and design controls are appropriate for organization.
- Maintain Design Trace Matrix, product specification, and detailed drawings associated with the RapidPulse system.
- Oversee and mentor the product development engineers and technicians in the development of new products and improvements to existing products.
- Identify new product development ideas and participate in the decision-making process to pursue the product and prioritize the efforts.
- Serve as design representative for regulatory audits.
- Ensure adequate materials and components are available when needed for manufacturing and testing activities.
- Prepare summary reports for the development team with regular updates on the physician feedback and case results.
- Write various evaluation, verification, animal and/or validation test protocols and reports to support the product development process through design controls.
- As necessary, build test equipment and conduct testing of product as needed.
- Maintain a working knowledge of company procedures, FDA Quality System Regulation, and ISO 13485.
- Evaluate new components and new vendors.
- Minimum 4-year engineering or science degree.
- Minimum 10 years’ experience in medical devices in continually increasing responsibilities of product development responsibility.
- Technical expertise in mechanical design, DFM and problem solving is required.
- Must have experience with manufacturing and fabrication processes (molding, CNC machining, extrusion, etc.).
- Demonstrated expertise with catheter development is strongly desired.
- Must have experience taking medical devices from concept through commercialization.
- Must have experience developing product test methods and driving design verification and validation testing.
- Must have experience and knowledge with Design for Manufacturing tools and transitioning a design into a manufacturing environment for commercial production.
- Must have previous experience in engineering management or project management.
- Must have thorough understanding of product development processes, manufacturing processes, quality assurance and project planning.
- Software skills should include MS Excel, MS Word, MS Project and Solidworks. Overall, must be computer literate. Some experience with electronics and software preferred.
- Possess personal qualities of integrity, credibility, and commitment to RapidPulse core values.
- Understanding of quality system regulations (ISO13485, 21CFR820)
- Must have strong interpersonal, written, and oral communication, organizational, and planning skills.
- Excellent presentation skills.
- Must be able to be a team player and work with cross-functional teams.
- Must be able to make decisions based on experience, facts and intelligent risk taking.
- Works independently with little guidance.
- Must be able to effectively interface with Physicians.
The work is conducted in an office environment, with some controlled cleanroom activities performed periodically. Experiments and testing are conducted in a laboratory environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
EXEMPT OR NON-EXEMPT: Exempt
TRAVEL REQUIREMENTS: ≤20%; Primarily US but may require international travel at times.
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