Summary: The Manufacturing Engineer will have a hands-on role supporting and improving 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 is eager to face engineering challenges and participate in ongoing process and equipment improvements.
Essential Duties and Responsibilities:
- Analyze and improve manufacturing process flow and floor layout to enhance safety, quality and efficiency
- Troubleshoot equipment problems and develop corrective actions
- Draft and execute validation protocols (IQ, OQ and PQ)
- Establish standard work and standard equipment operating parameters and properly document work instructions and standard operating procedures with clear and concise wording.
- Analyze quality problems and develop solutions and improvements
- Work with product development team to design manufacturing tooling and fixtures
- Support characterization and optimization of production processes though DOE, window studies, cycle time studies, etc., and properly document using laboratory notebook and/or technical study reports.
- Develop, implement, scale, verify, and validate manufacturing cells and processes
- Develop and implement automation solutions
- Work with Quality Control to resolve production and supplier quality issues
- Responsible for achieving device manufacturing and engineering operational objectives in support of commercial production, clinical trials, and new product development.
- Directly support production staff to ensure compliance with all Good Manufacturing Practices and Standard Operating Procedures as defined by the Company’s policies, practices, and procedures.
Qualifications:
- BS in Manufacturing, Mechanical, Industrial, Chemical, or Plastics Engineering
- 3+ years of experience in an equipment-intensive medical device manufacturing environment
- Proficient with SolidWorks with a demonstrated ability to design fixtures and tooling is preferred
- Experience with plastics processing (extrusion, injection molding, fiber forming) 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 are 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. .
