Summary: This Senior Manufacturing position will have a hands-on role managing and developing manufacturing processes 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, project management, and manufacturing experience, and is eager to face engineering challenges and participate in ongoing facility and equipment improvements.
Essential Duties and Responsibilities:
- Develop, implement, verify, and validate manufacturing processes in support of process flow and value stream mapping improvements for existing products, and in support of business development initiatives with customers creating new products
- Lead verification and validation exercises to support the launch of commercial manufacturing.
- Lead efforts to address non-conformances through the NCR/CAPA system - driving escalation when risk level warrants it
- Enhance manufacturing process flow and floor layout to enhance safety, quality, and efficiency
- Establish standard work and standard equipment operating parameters
- Work with the product development team to design manufacturing tooling and fixtures
- Develop and implement automation solutions
- Troubleshoot equipment problems and develop corrective actions
- Develop and execute program to reduce manufacturing costs and scrap rate.
- Analyze quality problems and develop solutions and improvements
- Work with Quality Control to resolve supplier quality issues
- Develop capital equipment proposals
- Responsible for achieving device manufacturing and engineering (M&E) operational objectives in support of process validation, clinical trial execution, product launch, quality, cost and safety.
- Delegate project tasks based on development staff members’ individual strengths, skill sets and experience levels
- Track and drive project performance, specifically to analyze the successful completion of short- and long-term goals.
- Meet budgetary objectives and make adjustments to project constraints based on financial analysis
- Develop comprehensive project plans and manage the execution of the plan. Must be able to present project plans and timeline to cross functional team.
Skills and Qualifications:
- BS in Manufacturing, Mechanical, Industrial or Plastics Engineering
- 8+ years’ experience in an equipment intensive ISO 9000 manufacturing environment
- Project management experience is Required
- Proficient with SolidWorks, with a demonstrated ability to design fixtures and tooling is preferred
- Experience with plastics processing (extrusion, injection molding, fiber forming) is a plus
- 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.
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .
