Production Supervisor
Manufacturing and Operations
Hiring Manager: Head of Operations and Quality
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Responsibilities:
- Recruit candidates and provide direct supervision of production technicians
- Provide feedback and direction to operators and/or technicians regarding their skill development and training needs
- Prepare build schedules, assign duties, and oversee the workflow and product quality
- Ensure quality processes, procedures, and safety on the manufacturing floor to ensure all standards, requirements, and regulations are met
- Supervise the activities of all employees to ensure compliance with all company quality and safety standards such as quality system, CFR 21 and ISO 13485
- Make informed decisions of resource allocation
- Initiate non-conformance material reports; maintain material transaction integrity by performing cycle counts, resolving inventory issues
- Establish and update plans and ensure execution of production expectations and requirements
- Establish and present performance metrics
- Utilize QMS systems to ensure production rigor
Requirements:
- College degree, preferably in a technical area or equivalent work experience
- 5+ years of relevant medical device production (i.e., catheters), assembly, manufacturing
- Highly collaborative approach to working with direct team and other stakeholders
- Ability to work in a regulated clean room most of the time to support job duties.
- Expertise with GMP, QMS, CFR 21 and ISO 13485
- Planning & production scaling
- Careful adherence to production and reporting tools, DHRs, MPIs, BOMs, SOPs
- Audit experience
- Excellent working knowledge continuous process improvement (Lean Six Sigma, preferred)
- Must be located within commuting distance to Santa Cruz or willing to relocate
Overview
Capstan Medical: Creating a new standard for minimally invasive structural heart treatment
At Capstan Medical, we’re driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we’ve pioneered a patient-optimized approach to repair and replace heart valves.
Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
Capstan Medical is uniquely positioned in Santa Cruz, this gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Come join us and become part of a team revolutionizing heart valve treatment.