Bachelor's degree in Manufacturing, Mechanical, Industrial, or Plastics Engineering
8+ years of experience in manufacturing/process engineering in regulated environments
Experience leading design and validation of production processes and tooling
Strong project management skills with cross-functional leadership experience
Proficiency in SolidWorks, particularly for designing fixtures and tooling
Exceptional organizational and communication skills
Six Sigma certification preferred
Experience with plastic processing techniques preferred.
Responsibilities
Develop, validate, and implement manufacturing processes for commercial production
Create process flow diagrams and value stream maps for products
Optimize manufacturing flow and facility layout for safety and efficiency
Establish standard work procedures and equipment parameters
Write clear work instructions and documentation for medical device manufacturing
Collaborate on quality issues and regulatory compliance
Design and implement manufacturing tooling and automation solutions
Lead continuous improvement initiatives for cost reduction and yield enhancement
Manage engineering projects from concept to execution
Mentor and train junior engineers and technicians.
Benefits
Opportunity to contribute to an innovation-driven Company
Potential for career growth in an early-stage company
Hands-on role in developing cutting-edge medical devices
Engagement in continuous improvement and process optimization
Being part of a team solving critical health complications.
Full Job Description
Summary
The Senior Manufacturing Engineer will play a pivotal, hands-on role in developing and optimizing manufacturing processes for cutting-edge, single-use medical devices made from novel biomaterials. This position offers a unique opportunity to contribute to an early-stage, innovation-driven company with strong potential for career growth. The ideal candidate brings deep expertise in process development, project management, and scalable manufacturing, and thrives in a fast-paced environment focused on continuous improvement across processes, facilities, and equipment.
Essential Duties and Responsibilities
As a key member of the manufacturing engineering team, you will be responsible for driving process excellence, supporting commercial production, and enabling future scalability of medical device manufacturing operations. Your core responsibilities will include:
Process Development & Optimization
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.
Documentation & Compliance
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.
Tooling, Equipment & Automation
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.
Continuous Improvement & Cost Reduction
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.
Project & Team Leadership
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.
Skills and Qualifications
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.
Prior work experience leading the development of plastic assembly, hardware assembly, electromechanical assembly and test processes is preferred.
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.
Six Sigma Green Belt or Black Belt (preferred).
Experience with plastics processing techniques such as extrusion, injection molding, and fiber forming (preferred)
Compensation Commensurate With Experience
$115,000-$145,000 USD
About Access Vascular, Inc.
Access Vascular, Inc. is a medical device company that develops and manufactures innovative products for the venous access market. The company's lead product, the HydroPICC?, is a peripherally inserted central catheter that is designed to reduce thrombotic occlusions and catheter-related bloodstream infections. The HydroPICC? is made of proprietary biomaterials that are designed to be more resistant to biofilm formation and thrombosis than traditional catheter materials. Access Vascular was founded in 2015 and is headquartered in Beverly, Massachusetts.
