Medical Device Manufacturing Engineer

Position: Medical Device Manufacturing Engineer

Only on W2, No C2C

Job Overview:

We are seeking a highly skilled and motivated Medical Device Manufacturing Engineer to join our dynamic team. As a mid-senior level engineer, you will be responsible for driving continuous improvement, optimizing manufacturing processes, and ensuring product quality in the production of medical devices. This role requires deep knowledge of manufacturing processes, engineering principles, and regulatory requirements in the medical device industry.

Key Responsibilities:

Process Optimization & Improvement:

Lead efforts to optimize manufacturing processes to improve efficiency, reduce waste, and enhance product quality. Identify opportunities for cost reduction and implement process improvements.

Manufacturing Support & Troubleshooting:

Provide day-to-day support to the manufacturing team, troubleshooting and resolving any equipment or process-related issues that arise during production.

Design for Manufacturability (DFM):

Collaborate with cross-functional teams (R&D, Quality, Regulatory, etc.) to ensure that new products are designed for manufacturability, ease of assembly, and cost-effectiveness.

Compliance & Quality Assurance:

Ensure all manufacturing processes comply with industry standards and regulations (e.g., ISO 13485, FDA QSR). Implement and maintain quality systems and practices in accordance with applicable regulations and guidelines.

Validation & Qualification:

Participate in the validation and qualification of new equipment and processes, ensuring they meet both product and regulatory requirements.

Equipment & Process Validation:

Support the validation of manufacturing processes and equipment, including writing protocols, executing validation runs, and analyzing results.

Cross-Functional Collaboration:

Work closely with other engineering teams, quality assurance, and production departments to resolve production issues and support continuous improvement initiatives.

Documentation & Reporting:

Develop and maintain thorough documentation, including process flow diagrams, work instructions, and quality reports. Ensure documentation aligns with regulatory requirements.

Project Management:

Lead or support projects related to process optimization, equipment upgrades, new product introductions, and other manufacturing-related initiatives. Manage project timelines, resources, and budgets effectively.

Qualifications:

Education:

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field. A Master's degree is a plus.

Experience:

5 years of experience in a medical device manufacturing environment, with a strong background in process engineering, equipment troubleshooting, and continuous improvement methodologies. Experience with ISO 13485 and FDA QSR regulations is required.

Technical Skills:

Expertise in manufacturing processes (injection molding, assembly, sterilization, etc.) used in medical device production.

Proficient in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools.

Knowledge of statistical process control (SPC), lean manufacturing, and Six Sigma principles.

Familiarity with risk management tools (e.g., FMEA, RCA).

Soft Skills:

Strong problem-solving and analytical abilities.

Excellent communication and collaboration skills, with the ability to work effectively across teams.

Attention to detail with a strong focus on quality and regulatory compliance.

Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications:

Certifications:

Six Sigma Green Belt/Black Belt, Lean Manufacturing certification, or other relevant certifications are a plus.