Manufacturing Engineer I

Job Summary

As part of a $60M+ manufacturer of surgical solutions for the medical industry, Manufacturing Engineer I (Disposables) is responsible for supporting manufacturing processes across disposable product lines. This role is expected to independently complete assigned tasks on time, resolve daily production issues, and support engineering projects. The Engineer I work closely with cross-functional teams to ensure process stability, product quality, and equipment performance. During this stage, the engineer is developing the ability to lead larger initiatives and is actively learning the tools and systems used to deliver engineering solutions in a regulated medical device environment.

Essential Job Duties and Responsibilities

• Sustain manufacturing processes for product lines, including day-to-day operations and supplier support.
• Provide engineering support for product design changes, equipment maintenance, and fixture/tooling updates needed to keep production running.
• Leverage expertise in clean-room assembly manufacturing, including PLCs, RF forming/welding, ultrasonic welding, automation, solvent and adhesive bonding and related techniques.
• Deliver on small to medium size cross-functional projects to resolve manufacturing challenges and improvement initiatives—defining scope, managing timelines and budgets, and coordinating with internal and external stakeholders.
• Support product design change activities by gathering input from clinical and manufacturing stakeholders, assisting in risk assessments, updating design documentation, executing test protocols, and helping coordinate the transfer of verified changes to production.
• Own and execute engineering projects and change orders, ensuring timely completion, accurate documentation, and effective coordination with cross-functional teams.
• Support Quality and Production for timely root cause analysis and corrective action implementations.
• Oversee IQ/OQ/PQ/PPQ execution and documentation for new and existing production equipment and product design changes.
• Identify, justify, and implement equipment upgrades, automation, and process improvement initiatives.
• Learn and apply Lean, Six Sigma, and Kaizen methodologies to reduce waste, increase throughput, and meet safety and quality targets.
• Analyze data, perform statistical evaluations, and generate detailed technical reports to support decisions and compliance.
• Ensure manufacturing systems and processes comply with internal standards and external regulatory requirements.
• Participate in design reviews and provide design for manufacturing (DFM) input to ensure scalable, cost-effective production for new product introduction (NPI).
• Utilize tools such as SolidWorks, FEA, DOE, capability analysis, Minitab, and JMP to support product and process design, troubleshooting, and optimization.
• Promote an owner’s mindset by ensuring that standardized work processes are followed.
• Apply elements of the NBS Next business model at the production floor level

Education and Experience Requirements

• Bachelor’s degree in Mechanical, Industrial, Manufacturing, Biomedical Engineering, or related field required.
• 0–3 years of engineering experience in a manufacturing or regulated environment preferred.
• Internship or co-op experience in medical device or cleanroom manufacturing is a plus.

Required Skills and Abilities

• Strong organizational and time management skills with the ability to independently complete assigned tasks.
• Proficient in Microsoft Office and SolidWorks; exposure to statistical tools (e.g., Excel, Minitab) preferred.
• Working knowledge of root cause analysis tools such as 5 Whys and Fishbone diagrams.
• Familiarity with engineering documentation, validation principles, and production support tools.
• Effective verbal and written communication skills, including report writing and cross-functional collaboration.
• Eagerness to learn and take ownership of deliverables with growing independence.

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 accommodation 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 computers and communication tools.
• May require travel up to 10% to suppliers 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 accommodation may be made to enable individuals with disabilities to perform the essential duties.

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