Demo

Principal Manufacturing Engineer

BioTalent
Burlington, MA Full Time
POSTED ON 2/16/2025
AVAILABLE BEFORE 5/11/2025

Job Title : Principal Manufacturing Engineer

Job Summary :

The Principal Manufacturing Engineer plays a critical role in driving continuous improvement within our high-volume medical device manufacturing environment. This highly impactful position will lead and execute complex projects, develop and implement innovative manufacturing processes, and mentor junior engineers.

Key Responsibilities :

  • Process Development & Optimization : Lead the development and optimization of manufacturing processes for new and existing medical devices, ensuring robust, efficient, and cost-effective production.
  • Utilize Lean Manufacturing principles (e.g., Six Sigma, Kaizen, 5S) to identify and eliminate waste in the manufacturing process.
  • Conduct process capability studies, analyze data, and implement corrective actions to improve yield and reduce defects.
  • Develop and validate new manufacturing equipment and tooling.
  • Project Management : Lead and manage cross-functional projects related to process improvement, equipment upgrades, and new product introductions.
  • Develop project plans, timelines, and budgets, ensuring projects are delivered on time and within scope.
  • Effectively communicate project progress, challenges, and solutions to stakeholders.
  • Technical Expertise : Deep understanding of manufacturing processes relevant to medical devices (e.g., injection molding, assembly, packaging, sterilization).
  • Proficient in statistical analysis tools and software (e.g., Minitab, JMP).
  • Strong knowledge of quality systems and regulatory requirements (e.g., ISO 13485, FDA regulations).
  • Team Leadership & Mentorship : Mentor and guide junior manufacturing engineers in their professional development.
  • Foster a collaborative and high-performing team environment.
  • Provide technical expertise and guidance to production personnel.
  • Continuous Improvement : Continuously seek and implement innovative solutions to improve manufacturing efficiency, quality, and cost-effectiveness.
  • Stay abreast of the latest industry trends and technologies in manufacturing.

Qualifications :

  • Bachelor's degree in Mechanical, Biomedical, or Industrial Engineering (or equivalent)
  • Minimum of 7 years of experience in medical device manufacturing, with a strong emphasis on high-volume production.
  • Proven experience in process development, optimization, and validation.
  • Strong project management skills with a demonstrated ability to deliver results on time and within budget.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Strong communication and interpersonal skills, with the ability to effectively communicate with all levels of the organization.
  • Experience with Lean Manufacturing principles and tools (e.g., Six Sigma, Kaizen, 5S).
  • Proficiency in statistical analysis software (e.g., Minitab, JMP).
  • Experience with quality systems and regulatory requirements (e.g., ISO 13485, FDA regulations).
  • Experience mentoring and developing junior engineers is a plus.
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