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Senior Mechanical Manager

3 months ago

Madurai, India Aurolab Full time

Job Description: Senior Mechanical Manager - Medical Device

Position Overview: We are seeking a Senior Mechanical Manager with specialized expertise in moulding, tool room operations, industrial design, sheet metal, and prototyping within the medical device industry. This pivotal role will lead our mechanical engineering efforts, overseeing the design, development, and manufacturing of innovative medical devices. The ideal candidate will bring extensive knowledge in these areas to ensure the successful execution of projects from conception through commercialization, while adhering to regulatory requirements and industry standards.

Key Responsibilities:

Technical Leadership:

  • Lead and manage a team of mechanical engineers specializing in moulding, tool room operations, industrial design, sheet metal, and prototyping.
  • Provide technical guidance, mentorship, and support to ensure the team's alignment with project goals and timelines.
  • Foster a culture of innovation and continuous improvement in mechanical design processes.

Mechanical Design and Development:

  • Oversee the design and development of mechanical components and systems for medical devices, focusing on moulding, sheet metal fabrication, and rapid prototyping.
  • Ensure designs comply with regulatory standards (FDA, ISO 13485, etc.) and manufacturing requirements.
  • Collaborate closely with cross-functional teams to integrate industrial design concepts into mechanical designs.

Project Management:

  • Manage project timelines, resource allocation, and budget for mechanical engineering activities related to moulding, tool room operations, industrial design, sheet metal, and prototyping.
  • Monitor progress, identify risks, and implement mitigation strategies to achieve project milestones and deliverables.
  • Communicate effectively with stakeholders and senior management on project status and recommendations.

Quality and Compliance:

  • Ensure mechanical designs and manufacturing processes meet regulatory requirements and industry standards.
  • Participate in design reviews, risk assessments, and verification/validation activities to maintain product quality and safety.
  • Drive initiatives to improve quality and efficiency in moulding, tool room operations, industrial design, sheet metal, and prototyping processes.

Vendor Management and Collaboration:

  • Collaborate with external vendors and suppliers for sourcing components, tooling, and manufacturing services.
  • Evaluate vendor capabilities, negotiate contracts, and manage relationships to ensure quality, cost-effectiveness, and adherence to project timelines.

Qualifications:

  • Bachelor’s degree in Mechanical Engineering or related field; advanced degree preferred.
  • Minimum of 15+ years of progressive experience in mechanical engineering within the medical device industry, with specific expertise in moulding, tool room operations, industrial design, sheet metal, and prototyping.
  • Proven track record of successfully leading and managing teams in the development and commercialization of medical devices.
  • In-depth knowledge of regulatory requirements (FDA QSR, ISO 13485, etc.) and standards applicable to medical device design and manufacturing.
  • Proficiency with CAD software (e.g., SolidWorks, Creo) and other design tools.

Preferred Skills:

  • Experience with project management methodologies and tools (PMP certification is a plus).
  • Strong analytical and problem-solving skills, with a proactive approach to addressing technical challenges.
  • Excellent communication skills, both verbal and written, with the ability to influence and collaborate effectively across functions.

Attributes:

  • Strong leadership abilities, with a focus on team development and mentorship.
  • Strategic thinker with the ability to prioritize and manage multiple projects.
  • Detail-oriented and organized, with a commitment to achieving high standards of quality and compliance.