Senior R&D Sustaining Engineer, Instruments - Pleasanton, CA
Senior R&D Sustaining Engineer, Instruments - Pleasanton, CA
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1 Vacancy
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 Calyxos instruments and accessories from concept to launch and beyond We are looking for a Senior R&D Sustaining Engineer to drive design solutions and support process enhancements for commercialized products working closely alongside the systems vision and sensors and software R&D teams to catalyze the advancement of an innovative single-use kidney stone treatment devices. 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 integrate and implement these solutions into our commercialized product(s).
In This Role You Will:
- Lead and inform the design development and qualification strategy for design-related product enhancements and line extensions in response to internal and/or external feedback.
- Lead design-related root cause analysis efforts and drive corrective and preventive actions.
- Serve as an R&D SME for projects lead by cross-functions and partner with cross-functional teams to gain alignment on qualification strategies.
- Create prototypes design fixturing devise feasibility studies and execute testing to draw meaningful conclusions and guide product development.
- Collaborate with the Post-Market Surveillance team to support effective root cause analysis of device issues returning from the field.
- Ensure design and development pathways maintain adherence to the design control process working with cross-functional partners to enable manufacturability reliability and scalability.
- Use SolidWorks to create well-defined models assemblies and engineering drawings.
- Support the generation of new or revised product requirements and engineering specifications.
- Create and execute protocols and author associated reports and risk documentation developing and validating new test methods as needed.
- Effectively communicate project progress results and risks to relevant stakeholders.
- Coordinate external testing activities such as sterilization packaging and biocompatibility testing as needed ensuring alignment with project goals and timelines.
Who You Will Report To:
- See Organizational Chart
Requirements:
- Bachelors degree in Mechanical Engineering Biomedical Engineering or a related field
- 5 years of medical device experience (4 with an advanced degree).
- Understanding of medical device regulations including ISO 13485 and FDA 21 CFR Part 820.
- 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.
- Track record of taking design concepts from prototyping stage through to design maturation.
- Proven design capabilities in two or more of the following key areas: injection molding electro-mechanical sub-systems catheter construction endoscope construction fluidics.
- Experience creating and running simulations (CFD FEA) to inform product development.
- Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.
- 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.
- 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 an attractive compensation package which includes:
- A competitive base salary of and variable incentive plan
- Stock options ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k) healthcare insurance and paid vacation
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not onlyvalued but alsoprioritized. 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 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.
Disclaimer:
At Calyxo we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:
- Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
- Verification of Identity: We do not extend job offers without first meeting candidates either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
- Beware of Scams: Calyxo will never request sensitive personal information such as your full name address phone number or identification documents via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of. If you receive a request for information from any other domain please contact us directly at to verify the legitimacy of the communication.
We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.
Required Experience:
Senior IC
Employment Type
Full Time
