Senior Manufacturing Process Engineer

1 week ago


Waltham, Massachusetts, United States Nova Biomedical Full time
Job Summary

Nova Biomedical is seeking a highly skilled Manufacturing Process Engineer II to support the daily technical activities of planar sensor manufacturing.

Key Responsibilities:
  • Technical Support: Provide day-to-day technical floor support to planar sensor operations, investigating and resolving issues that arise during manufacturing/processing.
  • Quality Control: Measure and inspect components for form, fit, function, and disposition nonconforming product as required.
  • Documentation: Document manufacturing variances and changes, and circulate for approval.
  • Process Development: Update and create manufacturing documentation, including AP, TP, OI, OP, Drawings, and Artwork, in accordance with Quality System Regulations (QSR's) and ISO standards.
  • Validation and Verification: Write and execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), and Continuous Improvement Studies/Evaluations.
  • Equipment Procurement: Research, specify, and procure new equipment for existing or new processes/assemblies.
  • Tooling and Fixtures: Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
  • Collaboration and Training: Collaborate with R&D and other manufacturing engineers to develop methods/processes to scale production and implement new products. Train assemblers and operators regarding new processes and assemblies.
  • Continuous Improvement: Lead continuous improvement programs to reduce cost and cycle times of products.
  • Lean Manufacturing: Examine and implement lean manufacturing techniques.
  • Interdepartmental Collaboration: Work cross-functionally with Consumable Engineering for automation and longer-term projects as appropriate.
Requirements:
  • Education: Bachelor's degree in Mechanical Engineering or Industrial Engineering.
  • Experience: 2-4 years of experience in an ISO 13485 environment.
  • Knowledge and Skills: Knowledge of lean manufacturing methods and practices. Six Sigma Green Belt (preferred).
Physical Requirements:
  • Hearing: Ability to hear.
  • Physical Demands: Ability to remain in a stationary position, often standing or sitting for prolonged periods. Ability to wear PPE. Ability to travel.
Skills and Competencies:
  • Interpersonal and Communication Skills: Strong interpersonal and communication skills.
  • Project Management: Strong project management fundamentals.
  • Time Management: Time management skills.
  • Lean Manufacturing Principles: Lean manufacturing principles.
  • Statistical Analysis: Minitab (and other statistical and graphical analysis applications).


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