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Lead Manufacturing Process Engineer

2 months ago

Billerica, Massachusetts, United States Access Vascular Inc Full time
Overview: This Lead Manufacturing Process Engineer role is integral to managing and enhancing production methodologies for cutting-edge single-use medical devices aimed at therapeutic solutions. This position provides a unique chance to contribute to a burgeoning start-up environment with significant opportunities for professional growth. The ideal candidate will possess expertise in process innovation, project oversight, and manufacturing operations, demonstrating a readiness to tackle engineering challenges while actively participating in ongoing improvements to facilities and equipment.

Key Responsibilities:
  • Design, implement, and validate manufacturing workflows to support enhancements in process flow and value stream mapping for current products, as well as to facilitate business development efforts for new product creation.
  • Oversee verification and validation activities to ensure successful commercial manufacturing launches.
  • Address non-conformances through the NCR/CAPA system, escalating issues when necessary based on risk assessments.
  • Optimize manufacturing process flows and facility layouts to improve safety, quality, and operational efficiency.
  • Establish standard operating procedures and equipment parameters.
  • Collaborate with product development teams to create manufacturing tools and fixtures.
  • Implement automation strategies to enhance production efficiency.
  • Diagnose equipment issues and formulate corrective action plans.
  • Develop and execute initiatives aimed at reducing manufacturing costs and minimizing scrap rates.
  • Analyze quality challenges and devise effective solutions and enhancements.
  • Work closely with Quality Control to address supplier-related quality concerns.
  • Prepare proposals for capital equipment investments.
  • Ensure the achievement of manufacturing and engineering operational goals related to process validation, clinical trials, product launches, quality, cost management, and safety.
  • Delegate project responsibilities based on the strengths and expertise of team members.
  • Monitor and drive project outcomes, focusing on the successful attainment of both short- and long-term objectives.
  • Manage budgetary goals and adjust project parameters based on financial evaluations.
  • Create detailed project plans and oversee their execution, including presenting timelines and plans to cross-functional teams.
Qualifications:
  • Bachelor's degree in Manufacturing, Mechanical, Industrial, or Plastics Engineering.
  • Minimum of 8 years of experience in a manufacturing environment adhering to ISO 9000 standards.
  • Proven project management experience is essential.
  • Proficiency in SolidWorks, with a demonstrated capability in designing fixtures and tooling preferred.
  • Experience in plastics processing (extrusion, injection molding, fiber forming) is advantageous.
  • Familiarity with ISO 13485 standards is a plus.
  • Ability to maintain organization and instill organizational skills within team members.
  • Strong verbal and written communication skills are critical.
  • Capacity to adapt to shifting priorities and manage multiple tasks in a dynamic setting.
Physical Requirements:

The physical demands outlined in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this role.

About Access Vascular:

Founded in 2015, Access Vascular is dedicated to addressing prevalent and costly complications associated with intravenous therapy, including infection, thrombosis, and phlebitis. The company is pioneering a range of venous access devices crafted from patented biomaterials that are highly biocompatible, resulting in significantly fewer complications.