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Lead Manufacturing Engineer

2 months ago

Cambridge, Massachusetts, United States NESCO Inc Full time

Lead Manufacturing Engineer (Experience in Medical Devices Required)

Overview: The Lead Manufacturing Engineer is essential in connecting Research & Development (R&D), Pilot Production, and large-scale commercial manufacturing. This position requires extensive collaboration across multiple departments to ensure the smooth transition of innovative medical products from initial development to market readiness. The focus is on ensuring that both design and manufacturing processes are clearly defined, scalable, and meet the highest standards of quality and compliance.

Key Responsibilities:

  • Design and enhance manufacturing processes for both capital and disposable medical devices, with a focus on assembly, testing, sterilization, and packaging to ensure cost-effectiveness and compliance.
  • Create detailed production assembly and component drawings.
  • Utilize Design for Manufacturing (DFM), Six Sigma, and LEAN methodologies to improve manufacturability and cost efficiency.
  • Assess and select contract manufacturing partners based on their capability to meet quality, cost, and timeline expectations.
  • Build strong partnerships with contract manufacturers to develop efficient and reliable production methods.
  • Act as the primary liaison between the project team and external manufacturing entities, ensuring aligned manufacturing strategies and activities.
  • Conduct comprehensive reviews of product specifications and CAD drawings to ensure compliance with industry standards.
  • Lead the validation and characterization of manufacturing processes, including conducting detailed experiments and tests to establish process capabilities and controls.
  • Develop and maintain critical documentation such as manufacturing instructions, equipment guidelines, and quality control measures.

Results Expected:

  • Effectively manage and update all design for manufacturability tasks, ensuring all processes are current and reflect best practices.
  • Maintain and periodically revise the Bill of Materials (BOM), work instructions, and process flow documents.
  • Oversee the creation and updates to process failure mode and effects analysis (pFMEA).

Qualifications:

  • A Bachelor's degree or higher in Mechanical Engineering.
  • More than five years of experience in engineering manufacturing processes within the medical device industry, with significant involvement in new product introduction and design transfer.
  • Proficiency in SolidWorks for complex assemblies and tooling designs.
  • Experience with contract manufacturing, particularly in the production of medical capital equipment and components.
  • Demonstrated expertise in process validation, design transfer, and working with sterilizable polymers and advanced fabrication techniques.
  • Strong knowledge of DFM, Six Sigma, LEAN, cGMP, and process validation principles.
  • Proficient in using Microsoft Office Suite and statistical tools such as Minitab or JMP for process analysis.

Preferred Skills:

  • Certifications in Lean and/or Six Sigma methodologies.

Work Environment:

  • This position requires full-time onsite presence.

NESCO Inc is committed to providing equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.