Job Description
Job Description
The Production Manager is responsible for leading day-to-day manufacturing operations to ensure the efficient, compliant, and timely production of respiratory therapy medical devices. This role involves managing production teams, driving operational excellence, and ensuring product quality and safety standards are consistently met. The Production Manager works closely with cross-functional teams to support continuous improvement, regulatory compliance, and delivery objectives. This position is on-site in Sandpoint, ID, Monday through Friday, 7am-3:30pm.
Essential Duties and Responsibilities:
- Lead and supervise daily production operations to ensure on-time delivery and quality output.
- Ensure manufacturing processes comply with applicable quality standards, including FDA 21 CFR Part 820, ISO 13485, and the company’s Quality Management System (QMS).
- Monitor production metrics (yield, efficiency, downtime, scrap) and implement corrective actions to achieve performance targets.
- Ensure personnel are properly trained and adhere to procedures, safety policies, and good manufacturing practices (GMP).
- Collaborate with engineering, quality, planning, and supply chain teams to resolve production issues and ensure smooth product flow.
- Drive continuous improvement initiatives using lean manufacturing principles to improve efficiency, reduce waste, and enhance product quality.
- Support manufacturing readiness for new product introductions (NPI), including process validation, equipment qualification, and training.
- Develop and maintain documentation such as work instructions, batch records, and training materials in compliance with QMS.
- Support internal and external audits by maintaining documentation and responding to findings related to production activities.
- Foster a culture of accountability, quality, and teamwork within the production department.
- Perform all other duties and responsibilities assigned.
Requirements
- Bachelor’s degree in Manufacturing, Engineering, Operations Management, or a related field.
- 5–7 years of experience in production or manufacturing leadership, preferably in the medical device or other regulated industry.
- Strong knowledge of GMP, QMS, and regulatory requirements such as FDA 21 CFR Part 820 and ISO 13485.
- Proven experience managing production teams and driving operational performance.
- Proficiency with MRP/ERP (Netsuite preferred) and eQMS systems.
- Familiarity with lean manufacturing, Six Sigma, or other continuous improvement methodologies.
- Strong communication, leadership, and cross-functional collaboration skills.
- Proficiency in production planning systems and manufacturing documentation
- Highly organized with strong analytical and problem-solving abilities, focused on process improvement and compliance.
Benefits
- Meaningful work in a rapidly growing company with opportunity for advancement
- Directly influence the quality of products and make a difference for patients worldwide
- Opportunities for professional and personal growth
- Pay: DOE
Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave , a wellness stipend and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.
By choosing a career at Sentec, you’re not just choosing a job – you’re embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide.
Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.