Access Vascular, Inc. · 10 hours ago
Senior Manufacturing Engineer
Billerica, MA
Full-time
Onsite
Senior Level, Lead/Staff
$110K/yr - $135K/yr
8+ years expAccess Vascular is an innovation-driven company focused on developing advanced venous access devices to improve intravenous therapy. The Senior Manufacturing Engineer will be responsible for optimizing manufacturing processes for medical devices, ensuring compliance with regulatory standards, and leading continuous improvement initiatives within the manufacturing engineering team.
Advanced MaterialsHealth CareManufacturingMedical DeviceProduct Management
Responsibilities
Work hands-on to develop, validate, and implement manufacturing processes to support commercial production and future scalability
Create and maintain process flow diagrams and value stream maps for current and future products
Optimize manufacturing process flow and facility layout to improve safety, quality, efficiency, and accommodate growth and new product introductions
Establish standard work procedures and equipment operating parameters
Write clear, concise work instructions and process documentation to support commercial medical device manufacturing, (including inspection procedures, test protocols, assembly drawings, equipment control documentation, and component drawings)
Work with cross functional teams to identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, CAPA related activities, design activities, and regulatory submissions
Collaborate with Quality Control to resolve supplier quality issues and ensure compliance with regulatory standards
Collaborate with product development teams to design and implement manufacturing tooling and fixtures
Identify, develop, and deploy automation solutions to improve process efficiency
Troubleshoot equipment issues and implement corrective actions
Develop capital equipment proposals to support manufacturing needs
Lead continuous improvement initiatives to reduce manufacturing costs, improve yield, and minimize scrap
Lead cross-functional efforts to streamline production through process improvements, test improvements, and product design changes
Analyze quality issues and implement corrective and preventive actions
Drive operational excellence through data-driven decision-making and lean manufacturing principles
Manage engineering projects from concept through execution, including developing comprehensive project plans and timelines
Present project updates and plans to cross-functional teams and stakeholders
Delegate tasks effectively based on team members’ strengths and experience
Monitor project performance and ensure alignment with short- and long-term organizational goals
Manage project budgets and adjust plans based on financial analysis
Serve as strong team player, supporting and assisting supervisor and colleagues when necessary and complying with all work safety rules and regulations
Provide mentorship and training to junior engineers, technicians, and interns
Qualification
Required
Bachelor's degree in Manufacturing, Mechanical, Industrial, or Plastics Engineering
Minimum of 8 years of manufacturing or process engineering experience in a regulated manufacturing environment, preferably FDA/ISO regulated medical device or medical equipment manufacturing
Prior experience leading the design, development, and validation of production processes, fixtures, and tooling
Proven project management experience, with the ability to lead cross-functional initiatives
Proficiency in SolidWorks, including demonstrated expertise in designing fixtures and tooling
Strong organizational skills with the ability to implement and promote structured workflows within engineering teams
Excellent verbal and written communication skills; capable of effectively communicating across all levels and disciplines of the organization
Adaptability to shifting priorities and ability to manage multiple tasks in a fast-paced, dynamic environment
Preferred
Prior work experience leading the development of plastic assembly, hardware assembly, electromechanical assembly and test processes
Six Sigma Green Belt or Black Belt
Experience with plastics processing techniques such as extrusion, injection molding, and fiber forming
Company
Access Vascular, Inc.
Access Vascular was founded to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$57.1MKey Investors
TVM Capital Life ScienceAngelMD
2023-10-31Series C· $22M
2021-03-03Series B· $20M
2019-09-26Series Unknown· $6M
Leadership Team
James Biggins
President and CEO
Recent News
Company data provided by crunchbase