Sr. Capital Manufacturing Engineer

hace 3 semanas

Tijuana, México Mammotome A tiempo completo

PROGRAM ASSIGNMENT RESPONSIBILITIES

As a member of the Capital Manufacturing Organization a Capital Manufacturing Engineer is responsible for troubleshooting manufacturing issues, ideation, root cause assessment, and remediation of those issues. Additionally the supplier management engineer will be responsible for the execution of projects both simple and complex relating the manufacture, packaging, or compliance of externally manufactured goods. The engineer shall understand manufacturing methods, assembly practices, root cause assessment, and quality standards of a medical device or similarly regulated product.

ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES)

**Team Member**
- Works on a cross-functional project team through all phases of the product development process.
- Includes planning and executing projects or designs from concept through the launch.
- Support and/or lead product changes after launch based on defined needs of the business.
- Providing technical expertise to the development of new goods and services.

**Manufacturing Oversite**
- Providing key interfaces between Mammotome and capital manufacturing sites, to ensure design for manufacturability, quality, cost, and on time delivery or finished devices.
- Providing technical expertise to the manufacture of capital equipment
- Managing the execution of projects at external and internal manufacturing sites.
- Providing technical guidance to contracted manufacturers
- Supporting Operations in the selection, assessment, and qualification suppliers ranging from component to full device assembly.
- Work closely with external manufacturers to identify process optimization opportunities.
- Maintain a high level of delivery on both project commitments and contract manufactured goods.

**Quality Management Systems**
- Maintain all necessary documentation requirements per a ISO13485 regulated quality management system.
- Knowledge of 21 CFR 820

GENERAL SKILLS/COMPETENCIES/SPECIALIZED KNOWLEDGE
- ** PCBA and Electronic Manufacturing Methods - **Operational understanding of PCBA manufacture.
- ** Electronic Design - **Ability to troubleshoot and identify opportunities for improvement to the manufacturability of PCBAs and electronic assemblies.
- ** Manufacturing Methods **- Basic understanding of broadly used manufacturing methods and controls.
- ** Process Controls** - Proficiency with process validation/qualification methods, statistical controls, and root cause assessment.
- ** Communication** - Communicates effectively at all levels of the organization. Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others. Communicates and listens effectively to develop and maintain key business relationships. Is comfortable with visual management techniques and providing daily/weekly updates on project progress.
- ** Interpersonal Skills **- Ability to work with co-workers and customers, both internal and external at all levels. Ability to professionally interact and build constructive and effective relationships with all levels and functions within the Company. Ability to effectively interface with others on behalf of the organization. Influences key business partners and customers to achieve mutually beneficial results.
- ** Initiative** - Ability to work well independently and exercise appropriate judgment under general direction. Ability to prioritize workload, goals and tasks consistent with the department and corporate objectives. Ability to take direction from multiple sources and manages conflicting priorities in an effective and efficient manner. Ability to multi-task, completing concurrent projects within given time frames and managing interruptions and change requests. Takes initiative to establish new processes and methods to support a variety of coordination activities.
- ** Problem Solving** - Uses rigorous logic to solve problems. Probes all sources for answers. Looks beyond the obvious. Enjoys solving tactical and process problems. Applies appropriate theory and principles, expert judgment, and cross-functional expertise to address a broad range of complex problems. Conflict analysis and resolution.
- ** Decision Making** - Makes timely, sound decisions based on analysis, experience, and judgment. Utilizes a high degree of creativity. Relies on extensive experience and good judgment to ensure that expectations are met and that business objectives are achieved.
- ** Adaptability** - Embraces and adapts to change and demonstrates a willingness to learn. Reactive to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances. Ability to respond quickly to change, and to prioritize actions to meet customer needs. Acts with a sense of urgency.
- ** Trust and Integrity **- Interacts with others in a way that gives them confidence in one’s intentions and those of the organization. Accepts responsibility for one’s own decisions and actions. Demon

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