Manufacturing Engineer I - Molding & Assembly Job

Job Summary

As part of a $70M+ manufacturer of surgical solutions for the medical industry, the Manufacturing Engineer I – Molding & Assembly is responsible for supporting manufacturing processes across disposable product lines, with a focus on molded plastic and silicone components and assembly technologies such as ultrasonic welding and adhesive dispensing. This role partners closely with external injection molding and silicone suppliers to support process capability, component quality, and design for manufacturability, while also providing hands-on support for internal assembly operations including ultrasonic welding and adhesive dispensing processes. The engineer is expected to independently complete assigned tasks, resolve daily production issues, and contribute to process improvements that enhance yield, reduce COPQ, and ensure equipment and process stability. During this stage, the engineer is developing the ability to lead larger initiatives while building further technical depth in molding processes, supplier management, and regulated medical device manufacturing systems.

Essential Job Duties and Responsibilities

* Sustain manufacturing processes for disposable product lines, including day-to-day operations.
* Develop foundational knowledge of injection molding and silicone molding processes while supporting senior engineers in supplier-related activities.
* Participate in supplier interactions, including technical reviews and issue resolution, to build supplier management capability.
* Provide engineering support for product design changes, equipment maintenance, and fixture/tooling updates required to maintain stable production.
* Train on and support in-house assembly processes, including ultrasonic welding, adhesive dispensing, solvent bonding, and automated cleanroom systems.
* Assist with troubleshooting and continuous improvement activities to improve yield, reduce COPQ, and enhance process stability.
* Support small to medium cross-functional projects to resolve manufacturing challenges and improve operational performance.
* Support product design changes and execute engineering change orders (ECOs), including documentation updates, testing, and implementation into production.
* Support Quality and Production teams in root cause investigations and implementation of corrective and preventive actions (CAPA), including supplier-related issues.
* Assist with validation activities (IQ/OQ/PQ/PPQ) for equipment, processes, and product changes.
* Analyze manufacturing and supplier performance data and generate technical reports to support decision-making.
* Support compliance of manufacturing processes, documentation, and supplier controls with internal quality systems and regulatory requirements (FDA, ISO).
* Utilize engineering tools (e.g., SolidWorks, Minitab, DOE) to support product and process development and troubleshooting.
* Support development of standardized work and process documentation to enable knowledge transfer and long-term continuity.
* Learn and apply elements of the NBS Next business model at the production floor level to support operational excellence initiatives.

Education and Experience Requirements

* Bachelor’s Degree in Mechanical, Manufacturing, Plastics/Polymer, Industrial, Biomedical Engineering, or related field required.
* 1–3 years of engineering experience in a manufacturing or regulated environment (medical device, pharmaceutical, or similar) preferred.
* Internship or co-op experience in medical device, plastics/injection molding, supplier quality, or cleanroom manufacturing is a plus.
* Exposure to manufacturing processes such as injection molding, silicone molding, or assembly technologies (e.g., ultrasonic welding, bonding) is preferred.

Required Skills and Abilities

* Strong organizational and time management skills with the ability to independently complete assigned tasks in a fast-paced manufacturing environment.
* Proficient in Microsoft Office and SolidWorks; exposure to statistical tools (e.g., Excel, Minitab) and data analysis techniques preferred.
* Working knowledge of problem-solving and root cause analysis tools such as 5 Whys, Fishbone diagrams, and basic CAPA methodologies.
* Familiarity with engineering documentation, validation principles (IQ/OQ/PQ), and production support processes in a regulated environment.
* Effective verbal and written communication skills, with the ability to collaborate cross-functionally and engage with external suppliers in a professional manner.
* Demonstrated ability and willingness to learn new manufacturing processes, including injection molding, silicone processing, and assembly techniques.
* Strong attention to detail with an emphasis on quality, compliance, and documentation accuracy.
* Eagerness to learn, take ownership of deliverables, and progressively build capability in supplier management, process development, and tooling support.

Working Conditions and Physical Demands

PHYSICAL DEMANDS:

The characteristics listed below are representative of the physical demands required by an individual to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

* May be required to sit, stand, or bend for extended periods.
* Regular use of a computer and communication tools.
* May require travel up to 15% to supplier or manufacturing sites.

WORK ENVIRONMENT:

The characteristics listed below are representative of the work environment typically encountered by an individual while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

* This role requires regular entry into controlled environments and cleanrooms. The engineer must follow all gowning protocols and adhere to cleanroom procedures in compliance with ISO Class standards.