Manufacturing Process Engineer II

4 days ago

Watertown, Massachusetts, United States Nova Biomedical Full time
Nova Biomedical Job Description

We are seeking a highly skilled Manufacturing Process Engineer II to join our team at Nova Biomedical in Waltham, MA. This individual will play a critical role in supporting the daily technical activities of planar sensor manufacturing.

Key Responsibilities:
  • Develop and optimize manufacturing processes to achieve increased output, quality, and cost goals.
  • Collect and analyze production data, applying statistical methods to document and diagram production processes and process improvements.
  • Contribute to the investigation of technical issues within the area of support.
  • Provide day-to-day technical floor support to planar sensor operations, investigating and resolving issues that arise during manufacturing/processing.
  • Measure and inspect components for form, fit, function, and disposition nonconforming product as required.
  • Document variances/changes and circulate for approval.
  • Update/create all forms of manufacturing documentation, conforming to Quality System Regulations (QSR's) and ISO standards.
  • Write and/or execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Validation Master Plans, and Continuous Improvement Studies/Evaluations.
  • Research, specify, and procure new equipment for existing or new processes/assemblies.
  • Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
  • 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.
  • Lead continuous improvement programs to reduce cost and cycle times of products.
  • Examine and implement lean manufacturing techniques.
  • Work cross-functionally with Consumable Engineering for automation and longer-term projects as appropriate.
Qualifications:
  • B.S. in Mechanical Engineering or Industrial Engineering is required.
  • 2-4 years of experience in an ISO 13485 environment is required.
  • Strong interpersonal and communication skills.
  • Strong Project Management Fundamentals.
  • Time Management skills.
  • Six Sigma.
  • Lean Manufacturing Principles.
  • Minitab (Other statistical and graphical analysis applications).
Physical Requirements:
  • Hearing.
  • Remaining in a stationary position, often standing or sitting for prolonged periods.
  • Ability to wear PPE.
  • Ability to travel.
Skills/Competencies:
  • Strong interpersonal and communication skills.
  • Strong Project Management Fundamentals.
  • Time Management skills.
  • Six Sigma.
  • Lean Manufacturing Principles.
  • Minitab (Other statistical and graphical analysis applications).
Education/Experience:
  • B.S. in Mechanical Engineering or Industrial Engineering is required.
  • 2-4 years of experience in an ISO 13485 environment is required.

We practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.

Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria, and an innovative scholarship program for children of employees.

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