Director, Instruments Engineering - Pleasanton, CA

Calyxo • Pleasanton, CA

353d • $228,000 - $238,000

About The Position

Calyxo is seeking a highly skilled and innovative leader for our Disposable Instruments Development Team, responsible for driving the design and development of advanced medical devices. The ideal candidate will lead the development of complex endoscopic instruments, including mechanical control systems, catheter shafts, and the integration of microelectrical subsystems. They will manage a cross-functional engineering team, providing support for existing product lines while spearheading the creation of next-generation solutions. The role also requires ensuring that all engineering efforts comply with industry standards and regulatory requirements, while aligning with strategic business objectives.

Requirements

• BS/MS in Mechanical Engineering or a related technical field is required. Advanced degree desirable.
• Catheter or endoscopic device design experience is a plus.
• 12+ years of related experience in medical device product development.
• A minimum of 5 years in a technical management role.
• Deep technical expertise in mechanism and control systems design, with aptitude with high volume design for injection molding and similar manufacturing technologies.
• Experience leading external vendors and contract manufacturers in the development of custom solutions.
• Exceptional problem-solving skills and experience leading multifunctional technical project teams through all development lifecycle phases.
• Experience in requirements definition, design reviews, change management and risk control.
• Demonstrated expertise with problem solving, root cause, and hazard analysis tools with the ability to lead and teach.
• Excellent technical writing and verbal communication skills are a must.
• Presentation capabilities that can be tailored anywhere from team-level to C-Suite are essential.
• Ability to work independently or in team setting required.
• Must be self-directed, self-motivated and be able to multi-task in a fast-paced environment with multiple priorities.
• Experience and involvement with MDRs, IDEs, and 510(k) filings is required.
• Knowledge and ability to interpret and follow applicable regulations, guidelines, and policy statements is required.
• Must have experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
• Ability to travel domestically and internationally up to 10% of the time.

Responsibilities

• Lead the Instruments Engineering team by providing technical direction that clearly supports corporate goals and objectives; foster an environment of collaboration, growth, learning, and achieving at Calyxo.
• Review and approve product designs for compliance with engineering principles, company standards, clinical requirements, and consensus standards.
• Prepare, train, and lead R&D engineering team through design control documentation and processes.
• Direct the integration of technical activities and related support activities (i.e., marketing, regulatory, quality, clinical, process development, and manufacturing).
• Plan and formulate the overall development program strategies and budgets; organize and assign resources according to project requirements.
• Work closely with Program Management on schedules and timelines that meet organizational needs and expectations.
• Work with cross-functional teams to define requirements for device performance and safety.
• Organize design reviews to ensure coherent design across instruments and SW interfaces.
• Establish best practices for product development to strengthen the technical expertise of the team.
• Create development plans for engineers, providing feedback, and establishing a growth mindset within the company.
• Work cross-functionally with other leaders to find efficiencies aimed at streamlining the product development process.
• Recommend implementation strategies for available or proposed products to meet product release cadence requirements.
• Foster a culture of continuous improvement and innovation among engineering and cross-functional teams.
• Mentor and develop engineering talent, promoting a collaborative and high-performance work environment.
• Hire top talent to meet business needs.

Benefits

• Competitive base salary range of $228,000 - $238,000
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Master's degree
• Number of Employees: 11-50 employees