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Manufacturing Engineer IV

Job description

Manufacturing Engineer IV
Our client is seeking a highly experienced and driven Manufacturing Engineer IV to lead complex manufacturing process development, validation, and continuous improvement efforts, with a strong focus on implantable medical devices. This senior-level role requires deep expertise in process optimization, supplier development, and cross-functional collaboration to ensure product quality, regulatory compliance, and operational efficiency.
As a technical leader, you will work closely with senior management, internal design teams, and external suppliers to optimize manufacturing processes, reduce costs, and deliver reliable, high-performance implantable components that meet stringent medical device standards. This role involves significant strategic input, mentoring of junior engineers, and hands-on engineering leadership.
Location: Orange County
Key Responsibilities
Process Development & Validation
  • Lead the development, validation, and optimization of complex manufacturing processes for polymeric implantable devices.
  • Drive design and implementation of robust manufacturing equipment and tooling.
  • Oversee and execute process characterization and validation protocols (IQ/OQ/PQ/PPQ).
  • Leverage advanced statistical tools (SPC, DOE, Six Sigma) to ensure process capability and product consistency.
  • Establish and maintain process documentation, including manufacturing work instructions and output specifications.
Project & Technical Leadership
  • Lead detailed manufacturing engineering phases of projects, from concept through commercial production.
  • Manage cross-functional initiatives that span supply chain, design, and quality teams.
  • Provide technical leadership during failure investigations and corrective/preventive action implementation.
  • Mentor and guide junior engineers and technicians on best practices and technical approaches.
Supplier & Equipment Management
  • Drive supplier process qualification and ongoing supplier performance improvements.
  • Evaluate, qualify, and maintain critical supplier processes and capabilities.
  • Lead equipment procurement, installation, and validation efforts at supplier locations.
Regulatory & Quality Compliance
  • Ensure compliance with all relevant regulatory standards (FDA QSR, ISO 13485, EU MDR).
  • Lead and support risk analysis efforts, including PFMEA and process hazard analysis.
  • Collaborate with regulatory affairs on submission content and strategy related to manufacturing and process changes.
Design for Manufacturability
  • Provide strategic input to design teams to enhance manufacturability and scalability of new products.
  • Facilitate design for manufacturing (DFM) reviews with internal teams and external partners.
Qualifications
  • BS in Mechanical, Manufacturing, or Biomedical Engineering (required); MS preferred.
  • 7–10 years of experience in manufacturing engineering, process development, and validation—ideally in the medical device industry.
  • Proven experience leading complex validation activities, including IQ/OQ/PQ/PPQ, TMVs, and pFMEAs.
  • Strong working knowledge of FDA regulations, ISO 13485, and GMP practices.
  • Demonstrated success in supplier development, outsourcing, and remote process control.
  • Expertise in polymer processing and cleanroom manufacturing environments is highly desirable.
  • Experience using statistical methods, including Design of Experiments (DOE) and Six Sigma tools.
  • Excellent organizational, communication, and project management skills.
  • Ability to work effectively in dynamic, fast-paced, and ambiguous environments.