REPORTS TO: Manager, Engineering

SUPERVISES: N/A

 

SYNOPSIS OF POSITION:

The position owns the manufacturing line for New Product Introductions (NPI) as well as supports improvements, modifications, and further deployment of sustaining production lines of Catheter products. The position participates in product development teams that specify, build, test, and challenge new product designs to improve efficacy, reliability, serviceability, manufacturability, and cost. This position requires high technical competence along with being a team player, self-starter, and possessing a can-do attitude.

 

ESSENTIAL FUNCTIONS:

 

• Design, document, assemble, qualify, and introduces production assembly/test/inspection fixtures and equipment. Designs and creates production equipment, fixtures and tests as needed to build the production line either internally or as needed at suppliers.
• Takes ownership of new products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, resolving manufacturability issues, and driving improvements for cost and efficiency.
• Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering team to enhance manufacturability and product cost. Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflow processes and detailed work instructions.
• Must possess strong communication skills to interface with operators, technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers. Mentors and sets project tasks for Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.
• Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions. Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies, and field returns.
• Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.
• Works jointly with Manufacturing Product Engineering, Manufacturing, Quality Control, and Quality Engineering to assure assigned processes successfully produce affected components or subassemblies according to applicable drawings, specs, and/or procedures.
• Assists Manufacturing Product Engineering in selecting vendors for contracted operations.
• Maintains in-depth knowledge of pertinent Manufacturing Technologies and disseminates this information as requested to various engineering and production groups.
• Responsible for programming and software integration of assigned CNC machine or other computerized process programming.  Ensure programs produce required results and that proper programming documentation is done.  Work with Manufacturing, Quality Control, and Quality Engineering to ensure operators are properly trained and system is properly verified/validated.
• Travel to vendors, trade shows and between facilities, possibly overseas.

 

ADDITIONAL RESPONSIBILITIES:

 

• Stays current with various assembly, material removal, inspection, and manufacturing systems technologies and philosophies.
• Provide various component cycle time estimates for product costing.
• Perform additional duties that may be assigned by Supervisor.

 

EDUCATION AND EXPERIENCE REQUIREMENTS:

 

• Four year technical degree and 8 years Manufacturing and/or Engineering experience or 10 years Manufacturing and/or Engineering experience.
• Demonstrated understanding of manufacturing processes including injection molding, machining, lamination, braiding and process capabilities. Demonstrated knowledge of mechanical assembly, testing, and inspection processes and Lean principles.
• Solid modeling/CAD experience (SolidWorks preferred).
• Strong problem solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments. 
• Excellent communication, organization, follow-up, and documentation skills. Comfortable interacting with technicians, engineers, and management all on a regular basis. 
• ISO 13485, 21 CFR Part 820, or experience in medical device manufacturing environment.
• Ability to successfully perform job duties in a fast pace, quick changing entrepreneurial environment.