Sr. Process Development Engineer

Summary: The Sr. Process Development Engineer will provide technical leadership in the innovation, design, development and optimization of new and modified manufacturing processes, tooling and equipment for innovative single use medical devices for therapeutic applications. The position offers the unique opportunity to partake in an early stage start-up company with career advancement opportunities. The right individual has process development and manufacturing experience in collaboration with R&D, and is eager to face engineering challenges and participate in ongoing process improvements.

Essential Duties and Responsibilities:

• Innovate, design, develop, optimize and implement manufacturing processes, procedure, tooling and equipment in support of process flow and value stream mapping improvements for existing products.
• Lead process development and process validation activities to support launch of commercial manufacturing
• Enhance manufacturing process flow and floor layout to enhance safety, quality and efficiency
• Perform process optimization through DOES and process capability studies
• Conduct new product design and development as required by new product development teams
• Establish standard work and standard equipment operating parameters
• Write manufacturing procedures and perform training of operators
• Demonstrates team leadership with a hands-on approach
• Develop and implement automation solutions
• Troubleshoot equipment problems and develop corrective actions
• Analyze quality problems and develop solutions and improvements
• Ensure adequate engineering studies, design verification and process validation are conduct such that well-developed products are introduced into manufacturing
• Work with Quality Control to resolve supplier quality issues
• Ability to use innovative technology to move products from R&D to Manufacturing
• May supervises and direct the daily activities of operators and technicians Oversees, monitors and coordinates team’s daily activities to remove inefficiency from the workflow.
• Responsible for achieving device manufacturing and engineering operational objectives in support of process validation, clinical trial execution, product launch, quality, cost and safety 
• Enforce compliance to all Good Manufacturing Practices and Standard Operating Procedures as defined by the Company’s policies, practices and procedures

Skills and Qualifications:

• BS in Manufacturing, Mechanical, Industrial or Plastics Engineering
• 5+ years experience in an equipment intensive ISO 9000 manufacturing environment, preferably in medical devices
• 1-2 years of direct supervisory experience is a plus
• Project management experience is preferred
• Proficient with SolidWorks, with a demonstrated ability to design fixtures and tooling is a plus
• Experience with plastics processing (extrusion, injection molding, fiber forming) and/or catheter production processes is preferred
• Exposure to ISO 13485 standards is a plus
• Demonstrated ability to stay organized and implement organizational skills into their team members
• Strong verbal and written communication skills is essential
• Ability to respond to changing priorities and to multi-task, in a dynamic environment

Physical Demands:

The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.