What are the responsibilities and job description for the Sr. Manufacturing Engineer - 205560 position at Medix™?
Looking for a Sr. or mid level Manufacturing Engineer with prior experience in the medical device industry. Experience with validation IQ/OQ/PQ, fixture design, and moving products from R&D into manufacturing is a huge plus.
This role offers your base salary a 7% bonus potential
Summary:
This role involves planning and coordinating work to align with project schedules, developing long-term plans under guidance, and independently analyzing complex problems. The position requires collaboration across teams and with suppliers to create, document, and implement procedures for assembling, testing, and manufacturing high-quality products. You will design, monitor, and optimize manufacturing processes, working closely with design engineers to achieve efficient, cost-effective production.
Essential Responsibilities:
- Conduct evaluation testing, verification, and validation per ISO, FDA, and corporate standards.
- Estimate production timelines, staffing, and costs to aid management decisions.
- Collaborate with management and staff to optimize production capabilities and schedules.
- Apply statistical methods to troubleshoot processes and perform root cause analysis.
- Enhance operations by introducing innovative methods, processes, and training programs.
- Oversee equipment procurement, installation, and validation (IQ/OQ/PQ).
- Investigate and systematically resolve production issues.
- Prepare manufacturing documentation for product production.
- Coordinate cross-functional projects and identify cost-reduction opportunities.
- Work with R&D and other teams to estimate costs for new designs.
- Collaborate with regulatory bodies to ensure compliance with safety and design standards.
- Support design-for-manufacturability efforts and facilitate product transitions from R&D to production.
- Generate and update assembly documentation (e.g., travelers, work instructions).
- Process engineering changes (ECNs) and develop cost-effective manufacturing methods.
- Provide production floor support and manage manufacturing costs.
Qualifications:
- Education: BS in Mechanical, Industrial, or Manufacturing Engineering.
- Experience: preferably in the medical device or other regulated industries.
- Strong understanding of engineering drawings/specifications and manufacturing process planning.
- Hands-on experience in machine shop practices (e.g., milling, turning, grinding) is a plus.
- Familiarity with automation and Six Sigma methodologies preferred.
- Experience with SolidWorks for mechanical design.
