Consumables Engineering Co-Op

Nova Biomedical is seeking a Consumable Engineering Co-op to join the Consumable Engineering team in Waltham, MA. This position will assist engineering staff in providing technical floor support to reagent, sensor, and tubing manufacturing operations, helping ensure the on-time shipment of high-quality products at an acceptable cost.

The Consumable Engineering Co-op will gain hands-on experience supporting regulated manufacturing operations through equipment qualification, process validation, tooling and fixture design, technical documentation, new equipment installation, and continuous improvement activities.

Responsibilities:

• Assist engineers in the creation and revision of manufacturing documentation, including Assembly Procedures, Test Procedures, Operating Instructions, and Operating Procedures, in compliance with Quality System Regulations and ISO standards.
• Assist with measurements of components to evaluate form, fit, and function in support of nonconforming product investigations.
• Assist with the development and execution of Installation Qualifications, Operational Qualifications, Performance Qualifications, validation activities, Design of Experiments, Process Failure Mode and Effects Analyses, Process Validation Master Plans, and continuous improvement studies and evaluations.
• Assist with the setup and installation of new equipment for existing or newly introduced processes and assemblies.
• Design tooling and fixtures for manufacturing processes and modify existing production equipment as needed.
• Assist with process improvement initiatives designed to enhance manufacturing quality, efficiency, and reliability.
• Provide direct technical support to manufacturing operations under the guidance of engineering staff.
• Collaborate with individuals across the organization, including Manufacturing, Research and Development, Quality Assurance, Quality Control, Marketing, Accounting, Purchasing, Planning, and Distribution.
• Maintain accurate and organized engineering records, data, and technical documentation.
• Support assigned engineering projects while meeting established quality requirements and project timelines.
• Communicate project progress, technical observations, and manufacturing concerns clearly to engineering team members.
• Follow all applicable safety, quality, documentation, and manufacturing procedures.

Experience Requirements:

• High School Diploma required.
• Current enrollment in an accredited college or university program leading to a bachelor’s degree in mechanical engineering required.
• No previous professional experience required.
• Strong interpersonal and communication skills.
• Strong time-management skills.
• Experience with SOLIDWORKS 3D modeling and drafting through coursework, projects, or previous work preferred.
• Experience with Microsoft Office applications.
• Ability to read and interpret technical documentation, drawings, and manufacturing procedures.
• Strong attention to detail and commitment to producing accurate, high-quality work.
• Ability to collect, organize, and evaluate engineering and manufacturing information.
• Ability to manage assigned responsibilities and meet project deadlines.
• Ability to work effectively both independently and as part of a multidisciplinary team.
• Interest in manufacturing engineering, process improvement, equipment qualification, validation, tooling, fixtures, and regulated product development.
• Willingness to learn and apply Quality System Regulation and ISO requirements within a manufacturing environment.

Physical Requirements and Working Conditions:

• Able to stand, walk, and move for extended periods.
• Capacity to lift and carry up to [25–50] pounds as required.
• Comfort with performing repetitive physical tasks.
• Able to bend, reach, stoop, or climb as needed.
• Willingness to work in varying environmental conditions (e.g., noise, temperature, equipment).
• Proficiency in operating tools, machinery, or technical equipment.
• Use of appropriate personal protective equipment (PPE) required.