Accessvascular

Sr. Process Development Engineer

Billerica, MA · Senior

Sponsorship not specified$110k-$145kDetected 27 days ago

Project ManagementProcess ImprovementSolidWorksFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationOrganizational Skills

About the role

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.

Perform process optimization through design of experiments and process capability studies
Engage early in the product design cycle as a manufacturing and process subject matter expert, providing design for manufacturability (DFM) input to development team to reduce downstream transfer risk and accelerate time to production readiness
Develop and implement automation solutions
Troubleshoot equipment problems and develop corrective actions
Analyze quality problems and develop solutions and improvements
Manage the end-to-end design transfer process, coordinating cross-functionally with R&D, Quality, Regulatory, and Operations to ensure complete and compliant product transfers; define and track transfer readiness criteria and milestone deliverables
Responsible for achieving device manufacturing and engineering operational objectives in support of product performance, process validation, quality, cost and safety
Lead design transfer activities from R&D to manufacturing, including development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with FDA QMSR and ISO 13485 requirements
Ensure adequate engineering studies, design verification, and process validation are completed such that well-characterized, transfer-ready processes are introduced into manufacturing; maintain traceability between process validation outcomes and design inputs

direct experience writing and executing process validation protocols (IQ/OQ/PQ) is required
Ability to respond to changing priorities and to multi-task, in a dynamic environment
BS in Manufacturing, Mechanical, Industrial or Plastics Engineering
7+ years experience in an equipment intensive medical device manufacturing environment
Proficient with SolidWorks, with a demonstrated ability to design, prototype, and evaluate fixtures and tooling is a plus
Solid understanding of ISO 13485, FDA QMSR, and design transfer requirements; direct experience writing and executing process validation protocols (IQ/OQ/PQ) is required
Demonstrated ability to stay organized and implement organizational skills into their team members
Strong verbal and written communication skills is essential

1-2 years of direct supervisory experience is a plus
Project management experience is preferred
Experience with plastics processing (extrusion, injection molding, fiber forming) is preferred

Commensurate With Experience
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..
$110,000 - $145,000 USD
About Access Vascular

Author, review, and maintain documentation in support of design transfer and process validation; ensure documentation meets Medical Device File requirements

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..

This listing is sourced directly from Accessvascular's careers page and normalized into a canonical job model.