Manufacturing Engineer- Medical Devices

The Manufacturing Engineer will play a crucial role in ensuring that production processes are efficient, effective, and aligned with company quality standards. This position will involve analyzing manufacturing processes, identifying areas for improvement, and developing systems and solutions that enhance productivity while maintaining product quality.

Key Responsibilities:

• Collaborate with cross-functional teams to design and implement manufacturing improvements.
• Conduct process simulations and analyses to identify bottlenecks and inefficiencies.
• Develop and maintain process documentation, including work instructions, process flows, and technical specifications.
• Implement continuous improvement initiatives using lean methodologies and Six Sigma principles.
• Support new product introductions by developing manufacturing processes.
• Conduct root cause analysis for manufacturing issues and devise corrective actions.
• Assess equipment performance and recommend enhancements or replacements as necessary.
• Train production staff on new processes and technologies.
• Ensure compliance with safety standards and regulatory requirements in all manufacturing activities.
• Gather and analyze data on production performance, quality metrics, and labor costs to drive decision-making.

Requirements

Qualifications:

• Bachelor's degree in Engineering (Mechanical, Industrial, or related field).
• 2+ years of experience in a manufacturing or engineering role.
• Strong knowledge of manufacturing processes and quality control methods.
• Proficiency in using CAD software and other engineering tools.
• Excellent communication and teamwork skills.
• Ability to work in a fast-paced environment and manage multiple projects concurrently.
• Strong analytical and problem-solving skills.
• Familiarity with lean manufacturing principles and Six Sigma methodologies is a plus.\

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

Physical Requirements:

• Ability to stand and walk for extended periods on manufacturing floor
• Capability to lift up to 25 pounds occasionally
• Manual dexterity required for handling small components and operating precision equipment
• Visual acuity necessary for inspecting small medical device components
• Ability to work in various positions including standing, sitting, bending, and reaching

Work Environment:

• Clean room manufacturing environment requiring adherence to gowning procedures
• Exposure to manufacturing equipment and potential noise levels requiring hearing protection
• Occasional exposure to chemicals and cleaning agents used in medical device manufacturing
• Temperature-controlled environment with potential for both warm and cool areas
• May require occasional travel to supplier locations or other company facilities (up to 10%)
• Standard business hours with occasional overtime during critical project phases or production issues

Safety Requirements:

• Must comply with all company safety policies and procedures
• Required to wear appropriate Personal Protective Equipment (PPE) including safety glasses, gloves, and clean room attire
• Participation in regular safety training and emergency response procedures

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Training & Development
• Free Food & Snacks
• Wellness Resources

Salary Range: $80,000 - $95,000 annually

Please note the salary information shown is a general guideline only. Salaries are based upon candidates’ skills, experience, and qualifications.

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.