Production Manager / Site Lead

Production Manager / Site Lead TeDan Surgical Innovations, Inc. - 2.0 Half Moon Bay, CA Job Details Full-time 1 day ago Qualifications Team leadership Safety regulations Environmental legislation Environmental compliance Manufacturing facility Production management software Environmental law compliance support Quality standards in production Biomedical regulatory compliance Managing manufacturing teams Manufacturing company experience

ISO 13485 FDA

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Company description:

TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.

Job Summary:

The Production Manager & Site Lead is the primary operational leader responsible for all activities at the Half Moon Bay, CA facility. This role ensures safe, compliant, and efficient production operations while acting as the on-site point of accountability for production, facilities, and site performance. The position partners closely with onsite engineering team to align production with new product introduction and customer project timelines. This role reports to the VP of Operations and is directly responsible for the team of production admin and direct labor staff on site.

Duties/Essential Job Functions:

Serve as primary point of responsibility for all site operations Own site KPIs including safety, quality, delivery, and cost Lead, coach, and develop production staff Manage production workflow and scheduling Partner with engineering to align production with NPI timelines Identify and resolve production bottlenecks Support NPD activities through prototype and V&V production activities Engage in transfer from NPD to Production both intra- and inter-site. Ensure readiness of work instructions, tooling, and training Ensure compliance with Cal/OSHA and environmental regulations Maintain adherence to FDA QSR and

ISO 13485

Drive CAPA and root cause activities Lead process improvement initiatives Oversee facility, equipment, and maintenance readiness Coordinate with Houston facility and travel as needed

Required Education/Experience:

Bachelor's degree in Engineering, Manufacturing, or related field. 7-10 years of manufacturing experience in regulated industry. 3-5 years leadership experience. Familiarity with MES and ERP systems. Misys, Syteline, and QuickBooks is advantageous. Knowledge of FDA QSR and

ISO 13485.

Familiarity with California safety and environmental regulations.

Physical Requirements:

Ability to stand for extended periods, lift up to 25 lbs occasionally, and work in a manufacturing environment. Reasonable Accommodations Tedan Surgical Innovations is an Equal Opportunity Employer. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position. Not the right fit? Let us know you're interested in a future opportunity by clicking Introduce Yourself in the top-right corner of the page or create an account to set up email alerts as new job postings become available that meet your interest!