Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Mechanical Engineer, Operations
2-3 years of industry experience, chemical to mechanical engineering backgrounds
Duties: In this role, the Engineer will use sound and proven engineering principles, best practices and concepts in order to assist in developing processes and process requirements from internal and external stakeholders. Working as a member of a LCM NPI team, this engineer will collaborate and communicate with other engineers, management, and cross functional team members. These individuals will provide technical leadership to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.
Participate in process development, definition and improvement, and other activities in the making of consumable products or support of processes/equipment used to sequence genomes.
Troubleshoot new product process issues related to yield, quality and throughput.
Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions into a production environment to meet project goals.
Analyze process test results, issue reports and make technical recommendations.
Work cross functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing products.
Represent Operations needs on development teams.
Ability to build relationships. Clear and consistent communication.
Data driven and action oriented
Manage/Participate in quality engineering activities, including process validations, CAPAs, complaint investigations, non-conformances, risk analysis and supplier surveillance Participate in manufacturing validation for new products being transitioned into production environment Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals.
Drive selection and qualification of critical suppliers for devices and volume manufacturing tooling
Work experience in the biotech, pharmaceutical, food packaging or medical device industry is desirable Experience in injection molding, reagent filling/packaging processes Material science knowledge of plastics Experience working in an ISO13485 or FDA certified environment is a plus.
Experience in high-volume production in a high-tech consumables industry is a plus.
Experience in production support and/or process development is desirable.
Experience with statistics, Statistical Process Control and DOE techniques is required.
High level problem solving and reasoning skills are required.
Experience with product development processes and project management skills are a plus.
Demonstrated ability to accomplish goals while working across departments is desirable.
High level computer skills are required. Intermediate level programming knowledge is a plus.
Demonstrate written and verbal communication skills and strong interpersonal skills to work with diverse cultures and global partners Demonstrate strong documentation skills (eg: Test reports, specifications, etc.) Experience using SAP or other ERP software and/or plant-related computer systems
Medical Device experience is a strong preference Experience is manufacturing or sustaining environment Experience in DFA or DFSS DMAIC experience
B.S./M.S./ PhD in Mechanical, Material Science, Bioengineering with 3-5+ years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.
Education: BSME, BSEE
Skills and Experience:
- FOOD PACKAGING
- MANUFACTURING TOOLING
- MECHANICAL ENGINEER
- MEDICAL DEVICE
- NEW PRODUCT INTRODUCTION
- PROCESS DEVELOPMENT
- PRODUCTION ENVIRONMENT
- PRODUCTION PROCESS
- RISK ANALYSIS
- TECHNICAL LEADERSHIP
- TEST REPORTS
- ENTERPRISE RESOURCE PLANNING
- EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
- INJECTION MOLDING
- MECHANICAL/ELECTRICAL ENGINEER
- MOLDING MACHINE
- PACKAGING PROCESSES
- PROBLEM SOLVING
- PROCESS CONTROL
- PRODUCT DEVELOPMENT
- PROJECT MANAGEMENT
- STATISTICAL PROCESS CONTROL
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Duration: 3-4 months
Locations: San Diego, CA
ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776