Senior Sustaining Engineer

1 week ago

Massachusetts, United States Mantell Associates Full time
Job Description

Mantell Associates is partnered with a commercial-stage Medical Technology firm, seeking a Senior Sustaining Engineer to join their growing team.

Key Responsibilities:
  • Manage engineering activities required to support products through the commercialized life cycle, ensuring seamless product delivery and customer satisfaction.
  • Provide engineering support for design and/or process changes of existing products, including ownership of change control documentation to support project execution and minimize business risk.
  • Develop and implement solutions for highly complex problems, reflecting an understanding of business objectives and cost implications, to drive process quality, productivity, and safety.
  • Design and develop manufacturing processes, tooling, and fixtures to meet business needs, enhancing process quality, productivity, and safety.
  • Provide engineering support for equipment qualifications and process verification and validation studies, including protocol development, execution, data analysis, and writing final reports.
  • Ensure appropriate process documentation and validation to lead manufacturing transfer and scale-up, ensuring compliance with regulatory requirements.
  • Develop and update work instructions, workmanship standards, and process documents as needed, providing required training for technicians and operators.
  • Monitor and assess the performance of manufacturing processes, working with R&D and Quality to promptly address emerging issues and implement solutions.
  • Provide engineering support for non-conforming products, customer complaints, product returns, and CAPAs, including leading root cause investigations and implementing short-term and/or long-term corrective actions to prevent recurrence and reduce business risk.
  • Support continuous improvement of existing manufacturing operations for increased quality, productivity, workflow, reliability, efficiency, and cost savings.
  • Support sourcing and approval of suppliers for manufacturing processes and equipment, ensuring compliance with regulatory requirements.
  • Provide support to resolve supply chain issues, component obsolescence issues, and identification of alternate suppliers, including interface with suppliers/customers as needed.
  • Provide support for regulatory approvals and responses to regulatory questions for existing products, ensuring compliance with regulatory requirements.
  • Proactively communicate project progress, risks, and recommendations to management as appropriate.
  • Perform other tasks and duties as required to contribute to the overall success of the team and organization.
Requirements:
  • Bachelor's degree in Mechanical or Biomedical Engineering (or related Engineering degree).
  • 5-8 years of hands-on experience in medical device development, production, or regulated industry.
  • Experience with ISO 13485 and FDA Quality System Regulations.
  • Experience with Minitab or other statistical evaluation software.
  • Lean Six Sigma training or certification and knowledge of statistical data analysis techniques (DOE, GR&R, Cpk, SPC).
  • Risk management experience (DFMEA, PFMEA).
  • CAD experience (preferably SolidWorks).
  • Demonstrated project management skills with ability to prioritize multiple concurrent projects in a fast-paced environment and identify/resolve issues as they arise with minimal supervision.
  • Cross-functional team player with a strong work ethic, strong engineering and problem-solving skills, creative thinking, good decision-making skills, high attention to detail, effective interpersonal skills, and excellent verbal/written communication skills.

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