Manufacturing Engineer

Invent Staffing; New York (NY); On-site; USD 111,000 - 164,000; Full time

Job summary

An established industry player is seeking a Manufacturing Engineer to optimize and develop processes for orthopedic implants. This role involves precision machining, regulatory compliance, and continuous improvement initiatives. You'll collaborate with cross-functional teams to tackle manufacturing challenges while ensuring adherence to industry standards. Join a forward-thinking company that values innovation and quality in the medical device sector, where your expertise will contribute to impactful advancements in healthcare technology.

Qualifications

• Proven experience in orthopedic implant manufacturing in a cleanroom environment.
• Strong understanding of precision machining and regulatory compliance.

Responsibilities

• Support the development of manufacturing processes for orthopedic implants.
• Ensure compliance with FDA regulations and ISO standards.

Skills

Orthopedic implant manufacturing

Precision machining

CNC milling

Quality Control (QC)

Lean manufacturing principles

Regulatory compliance

Project management

Communication skills

Education

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Tools

CNC machines

3D printing technologies

Sterilization equipment

Job description

• Support the development and optimization of existing and new manufacturing processes for orthopedic implants.
• Provide expertise in orthopedic implant manufacturing processes, including precision machining techniques, CNC milling, turning, laser marking, surface finishing (buffing and electropolishing), and ultrasonic cleaning.
• Assist in Design for Manufacturing (DFM) activities, providing input on process design and feasibility.
• Work with materials such as Ultra-High Molecular Weight Polyethylene (UHMWPE), Polyetheretherketone (PEEK), and Carbon Fiber-Reinforced PEEK.
• Implement and drive lean manufacturing principles and key performance indicators (KPIs) within the department.
• Manage and oversee maintenance and calibration of critical manufacturing equipment and systems to ensure optimal performance.
• Ensure compliance with FDA regulations and ISO standards, including 21 CFR Part 820, Part 807, Part 830, ISO 11607-1 and 11607-2.
• Lead and conduct validation activities (IQ/OQ/PQ) to ensure manufacturing processes meet regulatory and quality standards.
• Assist in product and manufacturing transfer activities, including production ramp-ups and scale-ups.
• Collaborate with cross-functional teams to address manufacturing challenges and implement continuous improvement initiatives.
• Ensure proper documentation of all activities and adhere to company and industry regulations.
• Participate in training and development activities to keep up-to-date with best practices, technology advancements, and regulatory changes.
• Support Quality Control (QC) and regulatory compliance processes for implant manufacturing.

Required Skills and Experience:

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Proven experience in orthopedic implant manufacturing, preferably in a cleanroom or regulated environment.
• Experience with precision machining, CNC milling/turning, live tooling, surface finishing, laser marking, ultrasonic cleaning, sterilization, and packaging.
• Familiarity with 3D printing and additive manufacturing technologies for medical devices.
• Hands-on experience in Quality Control (QC) and regulatory compliance (FDA, ISO 13485, 21 CFR Part 820, ISO 11607-1, ISO 11607-2).
• Strong understanding of metal and plastic cutting manufacturing processes.
• Experience with tooling design, fabrication, and process optimization.
• Ability to manage validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Solid understanding of packaging, cleanroom environments, and the requirements of sterilization and packaging processes for medical devices.
• Knowledge of safety and environmental standards within a manufacturing context.
• Excellent communication and project management skills.
• Experience with product/manufacturing transfer activities and scaling operations.
• Familiarity with lean manufacturing, continuous improvement principles, and KPI-driven results.

Desirable Qualifications:

• Experience in the medical device industry or aerospace manufacturing.
• Expertise in FDA regulations, ISO standards, and industry best practices for medical device manufacturing.
• Experience working in cross-functional teams to implement process improvements and troubleshoot manufacturing challenges.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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