Job Title: Manufacturing Engineer

Location: Minnetonka, MA

Duration: 12 Months

Job Description:

We are seeking a skilled and motivated Manufacturing Engineer with 4–6 years of experience to join our team for a 12-month contract. The ideal candidate will play a critical role in supporting manufacturing processes, improving operational efficiency, and ensuring compliance with industry standards in a highly regulated environment.

Responsibilities:

• Develop, optimize, and support manufacturing processes for medical devices and/or pharmaceutical products.
• Collaborate with cross-functional teams, including R&D, Quality, and Operations, to support new product introductions (NPI) and continuous improvement initiatives.
• Identify and implement process improvements to enhance efficiency, reduce costs, and maintain quality standards.
• Perform root cause analysis and implement corrective and preventive actions (CAPA) to resolve production issues.
• Prepare and update technical documentation, including work instructions, process flow diagrams, and validation protocols.
• Conduct process validation activities, such as IQ/OQ/PQ, to ensure compliance with regulatory and company requirements.
• Utilize Lean Six Sigma tools and methodologies to drive operational excellence.
• Monitor and analyze key performance indicators (KPIs) to ensure processes meet performance targets.
• Provide technical support and troubleshooting for manufacturing equipment and processes.
• Ensure adherence to FDA, ISO 13485, and other relevant regulatory standards.

Qualifications:

• Education: Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field.
• Experience: 4–6 years of experience in manufacturing engineering, preferably in medical device manufacturing, pharmaceuticals, or a similarly regulated industry.
• Technical Skills:
• Proficiency in CAD software and other engineering tools.
• Knowledge of process validation (IQ/OQ/PQ) and statistical analysis tools.
• Familiarity with Lean Manufacturing and Six Sigma principles.
• Hands-on experience with manufacturing equipment and automation systems.
• Soft Skills:
• Strong problem-solving and analytical abilities.
• Excellent communication and collaboration skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Regulatory Knowledge: Familiarity with FDA regulations, ISO 13485, and GMP standards is required.

Preferred Qualifications:

• Certification in Six Sigma (Green Belt or higher) or Lean Manufacturing.
• Experience with ERP systems and MES (Manufacturing Execution Systems).