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Manager of Manufacturing Engineering
2 months ago
WHO WE ARE:
Endotronix is a pioneering medical device organization dedicated to revolutionizing heart failure management, a chronic and progressive ailment characterized by the heart's inability to effectively pump blood. Our Cordella Heart Failure System (CHFS) encompasses advanced management tools designed for optimal care and early detection of deteriorating heart conditions. These user-friendly instruments enhance patient well-being and contribute to a decrease in hospitalizations, ultimately lowering healthcare expenses. With our recent FDA PMA approval, we are poised for expansion – an exciting opportunity awaits at Endotronix.
KEY RESPONSIBILITIES:
The Manufacturing Engineering Manager will oversee both direct and indirect reports in team-oriented and project-driven tasks. Core responsibilities will center on process innovation, control, and validation.
- Guide team members in achieving project objectives and collaborative goals.
- Facilitate process development initiatives to accommodate design modifications, enhance performance, and improve yield.
- Support in-house product manufacturing through the creation, review, and implementation of production documentation (including manufacturing instructions, inspection protocols, specifications, and routing).
- Engage in CAPA investigations, NCR resolutions, and other analytical activities.
- Collect, organize, and interpret data effectively.
- Educate staff on production methodologies.
- Develop and maintain risk documentation (PFMEA, etc.) pertinent to manufacturing processes and products.
- Assist in Design Transfer activities to manufacturing, encompassing all facets of Process Validation.
- Identify and validate capital equipment, including hands-on troubleshooting.
- Establish and monitor process tracking metrics to drive improvements (e.g., Scrap/Yield Tracking, Cost Tracking).
- Document and execute Process Validation for Equipment and Manufacturing Processes in IQ/OQ/PQ formats.
- Design and construct test fixtures for manufacturing and inspection purposes.
- Conduct Test Method Validation for inspections, including Gage R&R analysis.
- Collaborate with vendors and suppliers to ensure timely project completion.
- Perform additional duties as assigned by management.
QUALIFICATIONS:
- 3-5 years of experience in medical device engineering is preferred.
- Familiarity with ISO and FDA standards and regulations.
- Proven ability to work autonomously with minimal oversight.
- Exceptional verbal and written communication skills, especially in technical documentation.
- Strong organizational, interpersonal, and analytical abilities.
- Solid foundation in mechanical or electrical design.
- Experience in statistical data analysis.
- Proficiency in SolidWorks, Minitab, Labview, and MATLAB is advantageous.
- Competence in Microsoft Office Suite.
- Experience in risk analysis (PFMEA, DFMEA, etc.).
EDUCATIONAL BACKGROUND:
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Computer Engineering, or a related field.
PERSONAL ATTRIBUTES:
- Data-driven and hypothesis-oriented decision-maker focused on enhancing experiences for patients and clients.
- Proactive and iterative approach to problem-solving rather than striving for perfection.
- Adept at learning quickly, managing multiple tasks, and independently driving projects.
- Effective communicator and collaborator, capable of synthesizing insights from diverse stakeholders to deliver actionable results.
- A team-oriented individual who inspires collective success, embodying the principle that collaboration yields greater outcomes.
- Passionate about digital healthcare and utilizing data to create scalable innovative solutions.
CULTURE AT ENDOTRONIX:
- We prioritize open and honest communication, unafraid to confront challenges and develop actionable plans.
- Driven by a competitive spirit and a strong sense of initiative, we maintain an unwavering focus on achieving results.
- We value feedback and coaching, fostering a culture of continuous learning and improvement.
- Our team thrives in a complex environment, adeptly navigating challenges while influencing positive outcomes.
- We embrace an entrepreneurial mindset, remaining flexible yet results-oriented.
- We uphold high standards of intellectual curiosity, integrity, and capability.
- We promote humility and low ego, valuing performance without arrogance.
WORKING AT ENDOTRONIX:
- Our shared values foster trust and collaboration, enabling us to excel in delivering top-tier medical technology and customer service.
- We offer a competitive compensation package, comprehensive benefits including unlimited PTO, and an environment conducive to professional growth and success.
- Endotronix is an equal opportunity employer, committed to providing equal employment opportunities to all individuals, celebrating diversity and inclusion within our organization.
