Process Improvement Engineer

2 weeks ago


Billerica, Massachusetts, United States Access Vascular Inc Full time

Overview:

The Process Improvement Engineer will engage in a hands-on capacity to enhance and support manufacturing operations for cutting-edge single-use medical devices tailored for therapeutic uses.

This role presents a distinctive chance to contribute to a nascent start-up environment with potential for career growth. The ideal candidate is enthusiastic about tackling engineering challenges and actively participating in continuous process and equipment enhancements.

Key Responsibilities:
Evaluate and optimize manufacturing workflows and facility layouts to boost safety, quality, and productivity.
Diagnose equipment malfunctions and formulate corrective measures.
Create and implement validation protocols (IQ, OQ, and PQ).

Establish standard operating procedures and equipment operating parameters, ensuring clear and concise documentation of work instructions.

Investigate quality issues and devise solutions for improvements.
Collaborate with the product development team to design manufacturing tools and fixtures.

Assist in the characterization and optimization of production processes through Design of Experiments (DOE), cycle time studies, and window studies, documenting findings meticulously in laboratory notebooks or technical reports.

Develop, implement, scale, verify, and validate manufacturing cells and processes.
Innovate and implement automation strategies.
Partner with Quality Control to address production and supplier quality challenges.

Accountable for meeting device manufacturing and engineering operational goals in support of commercial production, clinical trials, and new product initiatives.

Provide direct support to production personnel to ensure adherence to all Good Manufacturing Practices and Standard Operating Procedures as outlined by the company's policies.


Qualifications:
Bachelor's degree in Manufacturing, Mechanical, Industrial, Chemical, or Plastics Engineering.
A minimum of 3 years of experience in a medical device manufacturing setting that is equipment-intensive.
Proficiency in SolidWorks with a proven ability to design fixtures and tooling is preferred.
Experience with plastic processing techniques (extrusion, injection molding, fiber forming) is advantageous.
Familiarity with ISO 13485 standards is a plus.
Demonstrated organizational skills and the ability to instill these skills in team members.
Strong verbal and written communication abilities are essential.
Capability to adapt to shifting priorities and manage multiple tasks in a dynamic setting.

Physical Requirements:


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

Access Vascular, Inc is an Equal Opportunity/Affirmative Action Employer.

All qualified candidates 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: Founded in 2015, Access Vascular aims to tackle the prevalent and costly complications associated with intravenous therapy, including infection, thrombosis, and phlebitis.

The company is developing a range of venous access devices crafted from patented biomaterials that exhibit high biocompatibility and have shown a sixfold reduction in complications.

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