Strip Manufacturing Engineer I

Nova Biomedical Corporation • Billerica, MA

3d • Onsite

About The Position

The Manufacturing Engineer 1 will play a key role in supporting and improving manufacturing and packaging processes for test strip products. This entry-level role focuses on process optimization, troubleshooting, and collaboration with cross-functional teams to ensure production quality, efficiency, and compliance with regulatory standards. This position will address any manufacturing issues on assigned projects. The main responsibilities will include troubleshooting and resolving test strip production equipment issues and implementing tools and fixtures. This role will collaborate on process improvement initiatives to enhance efficiency and reduce waste and will also participate in process improvement activities to optimize workflows and contribute to other improvement projects.

Requirements

• Ability to work in a fast-paced, hands-on environment to support continuous strip manufacturing and packaging operations
• Proficient with Microsoft Office and SolidWorks and/or AutoCAD
• Proficiency in interpreting technical specifications, schematics, and engineering drawings
• Strong written and oral communication skills with the ability to direct others as needed
• Knowledge of GMP, FDA QSRs, and ISO requirements
• BS in Manufacturing Engineering, Mechanical Engineering, or Electromechanical Engineering
• 0-2 years of engineering experience in a manufacturing environment is desirable, preferably in the medical device or biotechnology industry

Responsibilities

• Provide technical support for all manufacturing process equipment in the strip factory and packaging area
• Assist and guide technicians in troubleshooting and maintaining manufacturing equipment and processes.
• Support root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for equipment and process issues
• Assist with quality control inspections and product testing to ensure compliance with specifications
• Partner with Quality to investigate and resolve non-conformances and process deviations
• Execute verification and validation (V&V) protocols, including IQ/OQ/PQ activities
• Evaluate and disposition non-conforming parts and assemblies per established procedures
• Develop, update, and maintain Assembly Procedures, Test Procedures, Bills of Materials (BOMs), and technical documentation
• Prepare and process Engineering Change Orders (ECOs) and Manufacturing Variances (MVs)
• Complete required training curriculum and maintain compliance with training requirements
• Train assemblers and production personnel on assembly and test procedures
• Collaborate with Design, Quality, and Production teams to support New Product Introduction (NPI) activities
• Participate in Process FMEA (pFMEA) development, updates, and risk mitigation actions
• Contribute to design reviews and cross-functional problem-solving efforts
• Support continuous improvement initiatives and perform additional tasks as assigned

Benefits

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program
• Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level