Senior Process Development Manager
1 day ago
We are looking for a highly experienced Senior Manufacturing Engineer to join our team at Centerline Biomedical. As a key member of our manufacturing department, you will be responsible for leading the development, optimization, and implementation of manufacturing processes.
This role requires a strong background in manufacturing engineering, problem-solving, and cross-functional collaboration to enhance overall productivity and meet business goals.
Key Responsibilities:
- Lead the development and implementation of manufacturing processes that improve efficiency, reduce costs, and meet quality standards.
- Collaborate with design and R&D teams to ensure manufacturability of new products.
- Develop test methods and author process validation protocols and reports.
- Author and release equipment installation and operation qualifications.
- Collaborate with engineering to develop, document, and build prototypes, tooling, and fixtures to produce vascular medical devices according to design, quality specifications, and budget.
Technical Leadership:
- Provide technical expertise and guidance to resolve complex manufacturing issues.
- Lead troubleshooting and root cause analysis for process and equipment failures.
- Lead manufacturing start-up projects.
- Potential to manage team of technicians.
- Effectively communicate and collaborate with cross functional teams including; quality, R&D, management.
Project Management:
- Plan and manage manufacturing projects, ensuring timely delivery and alignment with organizational goals.
- Coordinate with cross-functional teams, including operations and quality.
- Monitor project performance, adjusting strategies as needed to achieve desired outcomes.
- Track material lead times, scrap rates, and product delivery schedules.
- Support product transfer from R&D to pilot production and full production through training and process development.
- Interact with outside vendors including third-party sterilizers and contract testing labs in order to accomplish project deliverables.
Estimated Salary Range: $120,000 - $160,000 per year, depending on experience and qualifications.
Requirements:
- Bachelor's degree in Mechanical, Industrial, Manufacturing Engineering, or a related field.
- 8+ years of experience in manufacturing engineering, with a proven track record of process improvement and successful project delivery.
- Knowledge of medical device testing and FDA requirements is highly preferred.
- Proficiency in CAD software, ERP systems, and manufacturing tools.
- Strong knowledge of Lean manufacturing principles and Six Sigma methodologies (certification is a plus).
- Project Management skills.
- Knowledge of manufacturing methods for vascular catheter systems is highly preferred.
- Lean manufacturing training and experience preferred.
- Familiarity with statistical process control and metrology.
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