Staff R&D Engineer, Instruments

Calyxo, Inc.; Fort Erie; On-site; USD 160,000 - 180,000; Full time

Job summary

An innovative medical device company is seeking a talented engineer to lead the design and development of groundbreaking kidney stone treatment devices. This role involves collaborating with a dynamic team to create next-generation solutions, ensuring seamless integration of mechanical systems with advanced technologies. You'll have the opportunity to shape the future of healthcare while working in a supportive and diverse environment that values creativity and innovation. If you're passionate about making a significant impact in the medical field, this is the perfect opportunity for you.

Benefits

Stock options

401(k)

Healthcare insurance

Paid time off

Qualifications

• 10+ years of medical device experience in a related field.
• Understanding of medical device regulations including ISO 13485.
• Experience leading technical teams and mentoring engineers.

Responsibilities

• Lead design and development of new single-use devices.
• Ensure adherence to design control processes.
• Create prototypes and execute testing to guide product development.

Skills

SolidWorks

DFX principles

Design for manufacturability

Statistical methods

Problem-solving

Collaboration

Education

Bachelor's degree in Mechanical Engineering

Advanced degree in a related field

Tools

CFD simulations

FEA simulations

Job description

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

The Instruments Engineering team is a highly energetic and actively growing team that is responsible for developing and ultimately driving Calyxo's instruments and accessories through to launch. In this role, you will lead the design and development of new solutions for released and next-generation devices and accessories, ensuring seamless integration of mechanical systems with vision, sensors, and software, and catalyzing the advancement of an innovative, single-use kidney stone treatment device. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to successfully drive these novel concepts through all phases of development to commercialization.

In This Role You Will:

• Lead the design and development of new single-use devices and accessories, serving as a technical lead for the team, and a core team lead for R&D and cross-functional project teams.


• Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.


• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.


• Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding.


• Define and lead qualification strategies for new designs or processes, working in partnership with other teams across the organization to gain alignment.


• Meaningfully translate customer requirements into new or revised product requirements and engineering specifications.


• Use SolidWorks to create well-defined models, assemblies, and engineering drawings.


• Generate purposeful Intellectual Property (IP) and contribute to the overall IP portfolio.


• Effectively communicate project progress, results, and risks to relevant stakeholders.


• Develop test methods, create and execute protocols, and author associated reports and risk documentation.


• Drive communication with suppliers to progress activities relevant to component or subassembly development.


• Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines.

Requirements:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field and a minimum of 10 years of medical device experience, OR


• Advanced degree in a related field and a minimum of 9 years of medical device experience.


• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.


• Experience leading technical teams and providing mentorship to other engineers.


• Proven ability to apply DFX principles to create designs that can scale.


• Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T.


• Proven design capabilities in two or more of the following key areas: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics.


• Experience creating and running simulations (CFD, FEA) to inform product development.


• Proficiency in conducting structured design of experiments (DOEs) and using statistical methods to analyze data.


• Proven track record of taking new designs from concept stage through to commercialization.


• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.


• Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.


• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.


• Work location: Pleasanton, CA


• Travel: less than 10%


• Full time employment


• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer a compensation plan as follows:

• Competitive base salary range of $160,000 - $180,000


• Stock options - ownership and a stake in growing a mission-driven company


• Employee benefits package that includes 401(k), healthcare insurance and paid time off

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.